Spring Fertility (“Spring”), a leading provider of fertility care in Northern California, today announced it has received a significant growth equity investment from Wildcat Capital Management, a New York based family office. Since opening in 2016, Spring has quickly become the premier fertility center in Northern California and one of the fastest growing fertility centers in the country by achieving consistently superior clinical results with high patient satisfaction scores. Spring anticipates using this investment to fuel further scientific innovation and expand access to its care platform in the Bay Area and across North America. Spring currently serves patients from offices in San Francisco, East Bay and Silicon Valley. Advanced procedures are performed in an innovative, state of the art lab which deploys unique, customized technology that more accurately replicates the body’s internal environment in the lab.
“We are proud to partner with Spring as it advances the science of fertility and delivers the highest-quality care possible. Spring’s focus on innovation and their relentless pursuit of improved clinical, lab, and experiential standards uniquely position it as a leader in the fertility sector.” Spring was founded by Drs. Peter Klatsky and Nam Tran, as they sought to change the experience and outcomes for patients seeking fertility care. Drs. Klatsky and Tran will retain majority ownership post-transaction. “Wildcat is excited to support the Spring team as they continue to re-invent the patient experience while providing exceptional clinical outcomes,” said Drew Tarlow, Principal at Wildcat Capital Management. “We are proud to partner with Spring as it advances the science of fertility and delivers the highest-quality care possible. Spring’s focus on innovation and their relentless pursuit of improved clinical, lab, and experiential standards uniquely position it as a leader in the fertility sector.” “After years of directing research at the best academic centers in the country, it’s rewarding to see those innovations quickly translate into patient care,” explains Spring’s Scientific Director Nam Tran, MD, PhD. “We have been able to accomplish several ‘firsts’ in our lab and are excited to use this investment to further develop our scientific research program and continue to innovate novel therapeutic options to help our patients. Our unique egg to embryo environmental controls have reduced attrition by over 25% from fertilization through embryo development. This means a significantly higher chance of success with fewer disappointing outcomes.” “We exist to help our patients pursue and achieve their goals. Our desire to innovate while improving access and quality aligns with Wildcat’s patient, long-term approach,” said Dr. Peter Klatsky of Spring Fertility. “With Wildcat’s investment, Spring will have the resources to continue expanding access while investing in our clinical and technological capabilities to create a differentiated and superior experience for our patients, employees, and physicians.” Bass Berry Sims advised Spring Fertility on the transaction, and McDermott Will & Emery, Alvarez & Marsal, Aon, and Avalere advised Wildcat Capital Management. About Spring Fertility Spring Fertility was founded by leading physicians with the goal of redefining the reproductive and fertility patient experience to improve comfort, communication and care while advancing scientific excellence. It quickly became the premier fertility platform in Northern California, and one of the country’s fastest growing. The Company was founded in 2016 by Peter Klatsky, MD, MPH and Nam Tran, MD, PhD and provides a broad range of fertility treatments including IVF and egg freezing. Spring’s state-of-the-art fertility lab is located in San Francisco and the company operates patient centers in Oakland and Redwood City. Source: Spring Fertility
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Allen Davidoff, Co-Founder, President and CEO XORTX Therapeutics (CSE:XRX; OTCQB:XRTXF) is awaiting several key milestones during the next few months as it works to redefine how progressive kidney disease is treated. “Our two lead programs are targeting uric acid lowering, which has been shown to have an important clinical effect in this disease,” Allen Davidoff, co-founder, president and CEO, says in an interview with BioTuesdays. “We have a strong IP portfolio and well established proof-of-concept for our XRx-008 to treat autosomal dominant polycystic kidney disease (ADPKD), an orphan market, and XRx-221 for Type 2 diabetic nephropathy (T2DN), a large market,” he adds. In August, XORTX expects to receive top line results from a Phase 2a study of XRx-221 in T2DN, under a co-development deal with Japan’s Teijin Pharma. XORTX also is expecting a European patent for its diabetic nephropathy program and is readying strategic discussions. ADPKD is a life-threatening genetic disease, where fluid-filled cysts develop and enlarge in both kidneys, eventually leading to kidney failure. More than 50% of people with ADPKD will develop kidney failure by age 50. Once a person has kidney failure, dialysis or a transplant is the only option. Dr. Davidoff explains that elevated uric acid is a bad actor in kidney disease. There is a substantial body of independent Phase 2 clinical trial evidence that suggests high levels of uric acid can lead to high blood pressure, vascular damage, kidney inflammation, fibrosis, decline in the kidney’s filtering capacity and high levels of protein in urine. Uric Acid (UA): a Bad Actor in Kidney Disease A peer-reviewed study published in BMC Nephrology in 2014 found that reducing uric acid levels in ADPKD patients increased kidney-filtering capacity by some 175% after one year, effectively reversing the course of the disease. XORTX’s patent portfolio covering uric acid-lowering agents used in progressive kidney disease extends to as late as 2037. Dr. Davidoff says that recent discussions with the FDA about XORTX's orphan drug program in ADPKD resulted in an accelerated clinical development program, with guidance that the program could advance to a pivotal Phase 3 registration trial under a special protocol approval (SPA). “The FDA discussion that clarified this approach, effectively halved the development time and cost for the ADPKD program and accelerated the opportunity to have a marketed drug for ADPKD patients within four years,” he adds. Dr. Davidoff also indicates that more than 10 international specialty pharma companies have reached out to XORTX, expressing interest in licensing the ADPKD program a variety of jurisdictions. XORTX’s XRx-008 drug candidate is a proprietary formulation of Oxypurinol, which already has an established safety and efficacy data. “Our formulation of XRx-008 has three times greater bioavailability than Oxypurinol alone, enabling increased oral dosing ranges, while its improved tolerability increases compliance and supports chronic dosing,” he contends. There are some 120,000 ADPKD patients in the U.S. and, at a projected revenue per patient of $30,000 a year, XRx-008 has the potential to generate annual peak sales of nearly $2-billion in the US alone. At the beginning of 2020, XORTX plans to conduct a one-month bioavailability study with XRx-008, ahead of initiating a pivotal study under a SPA in the first half of 2020. Data would read out in 2022. “If we can demonstrate slowing or reversing the decline in the rate of kidney filtration by 35% to 40%, we would reach the FDA’s approval threshold,” Dr. Davidoff suggests. Currently published pilot trials in ADPKD and T2DN both show clinically meaningful benefit for individuals far in excess of this threshold. XORTX intends to file an NDA for XRx-008 under accelerated review at the beginning of 2023 and achieve marketing approval one year later. The company's second program, to slow or even reverse progression of diabetic kidney disease, is in a co-development deal with Teijin Pharma that grants XORTX exclusive global rights to XRx-221. “We are indeed honored that Teijin has agreed to allow the XORTX Therapeutics’ development team act as the custodian for this next generation uric acid lowering drug,” Dr. Davidoff says. The agreement provides exclusive global rights to develop the drug for kidney diseases, including T2DN. XORTX views this milestone as a validation of the expertise and patent protection that XORTX provides. Dr. Davidoff says that following Teijin’s ongoing Phase 2a diabetic kidney study, which reads out in August, the company hopes to begin a Phase 2b clinical trial with some 400 T2DN patients to demonstrate the drug candidate’s ability to improve glomerular filtration rate – XORTX’s preferred, and an FDA approvable endpoint. “This potent, next generation uric acid-lowering drug candidate has the ability to re-define how T2DN is treated in the future,” he suggests, adding that a positive read out in August should “further solidify XORTX’s position as a leading global kidney disease drug developer.” Dr. Davidoff also points out that controlling uric acid levels in diabetes patients may delay progression to end-stage kidney disease, where patients must be on dialysis for four hours a day and only 50% of patients survive two years. There are no approved diabetic nephropathy drugs to treat progressive kidney disease due to uric acid injury, he notes. “A therapy that maintains and extends kidney health can redefine kidney disease treatment in the future.” Dr. Davidoff says the company’s treatment for progressive kidney disease, XRx-221, is a next generation xanthine oxidoreductase inhibitor, targeting T2DN. “Testing to date suggests that the drug candidate’s high potency inhibits production of uric acid in a large percentage of individuals, decreasing and maintaining serum uric acid levels in low-to-normal target range.” A study by Spanish researchers published in the peer-reviewed American Journal of Kidney Disease in 2015 showed that after seven years, decreasing serum uric acid in chronic kidney disease patients had the potential to halve the number of individuals who needed dialysis, and cut hospitalizations for renal events by 70%. Dr. Davidoff points out that in the U.S., the government covers the $90,000 average annual cost per patient undergoing dialysis. There are now some 10 million people with diabetic nephropathy in the U.S., with forecasts growing to 17 million by 2035. “And with 700,000-to-800,000 people starting dialysis each year, the savings to the health care system would be in the billions of dollars,” he adds. XORTX hopes to begin a Phase 2b trial with XRx-221 in 400 T2DN patients in 2020, with data expected at the end of 2022. If the study were successful, the company would begin two Phase 3 trials in 2023, releasing data in 2024 and 2025, which could lead to U.S. marketing approval in 2026. The two Phase 3 pivotal studies for the T2DN program are expected to enroll 1,200 patients each. Along with the Phase 2b study in 2020, the company also plans to conduct a pilot adolescent study with individuals aged 16-to-25. Data should be available by mid-2022. “This group of individuals is particularly at risk of uric acid injury to their kidneys. Recent studies suggest they may respond well to uric acid lowering, so we would expect data to provide some guidance how to proceed to our pivotal studies the following year,” Dr. Davidoff suggests. • • • • •To connect with XORTX, or any of the other companies featured on BioTuesdays, send us an email at editor@biotuesdays.com. via Features | BioTuesdays by Kilmer Lucas http://bit.ly/2QILWek Medical Facilities Corporation (MFC) (TSX: DR) announced that, through its MFC Nueterra Partnership, it plans to develop a new ambulatory surgery center (ASC) located at the campus of St. Luke’s Hospital in Chesterfield, Missouri. The ASC (named St. Luke’s Surgery Center of Chesterfield) will be MFC's second in the state.
The ASC will initially offer five specialties, including orthopedics, gynecology, gastrointestinal (GI), plastic surgery and general surgery. The surgery center will feature extended care rooms to accommodate outpatient surgeries such as total joint replacement of the knee and hip. The surgery center will feature extended care rooms to accommodate outpatient surgeries such as total joint replacement of the knee and hip. Thirteen local physicians have joined the development as owner/partners. Both the number of partner physicians and the specialties will likely increase before or after the new facility opens. The ASC is targeted for a spring 2020 opening. Local architectural firm Archimages, Inc. has been engaged as the architect for the project. The multi-specialty St. Luke’s Surgery Center of Chesterfield, while jointly owned by St. Luke’s Hospital, MFC, NueHealth and local physicians, will also be available to other physicians beyond the ownership group, based on availability. While terms of the partnership were not disclosed, the in market tuck-in opportunity is expected to be highly accretive. Growing the number of ASCs helps to further diversify MFC’s revenue base and builds an attractive network as payors push more procedures into the lower-cost ASC model. Alan Joslyn, President and CEO Oragenics (NYSE American: OGEN) is leveraging its synthetic biology platforms to address two significant unmet medical needs: oral mucositis (OM) and multi drug-resistant (MDR) bacterial infections. According to the CDC, some 700,000 newly-diagnosed cancer patients are receiving chemotherapy and radiotherapy in the U.S., putting them at increased risk of developing OM, a serious and debilitating breakdown of the mucosal lining of the mouth. “Patients will describe the pain as chewing on razorblades or barbed wire - they’re in a significant amount of pain. What we’re trying to do is prevent this from happening in the first place,” Alan Joslyn, Ph.D., president and CEO, says in an interview with BioTuesdays. Mouth ulcers can take up to two weeks to heal, while the pain associated with OM can lead to the inability to eat and even drink, requiring that patients be hospitalized. “Patients with severe OM are three-to-four times more likely to have an interruption in their chemotherapy regimen, and in head and neck cancer, patients are twice as likely to have an interruption in their radiation regimen. Both of these result in worse outcomes,” Dr. Joslyn points out. Economic and Clinical Impact of Severe OM “Because of the severity of patients’ ulcerations, they’ll likely require total parenteral nutrition, which is associated with an average nine-day hospital stay. As you can imagine, just the direct cost related to the hospitalization drives up the economic impact,” he adds. Oragenics’ lead candidate, AG013, consists of genetically modified Lactococcus lactis, bacteria commonly found in dairy products and yogurt. The bacteria are modified to express human trefoil factor family 1 (hTFF1), a peptide naturally secreted in saliva that creates a protective mucosal barrier and promotes epithelial regrowth. The hTTF1-expressing bacteria are produced in a large fermenter, rinsed, and freeze dried to produce AG013. “The cost of goods is extremely low for this technology, so it’s elegant and cost-effective at the same time,” Dr. Joslyn says. The powder is mixed with a raspberry-flavored solution, which patients use to rinse their mouths after every meal. The bacteria stick to the lining of the mouth, and after producing hTTF1 for about two hours, the bacteria die a pre-programmed cell death. AG013 in Action Dr. Joslyn explains that when Oragenics inserted the hTTF1 gene into the genome of L. lactis, they removed a gene the bacteria require to make DNA. “We’ve placed a kill switch into these bacteria, so they will grow to the point they want to split into two bacteria but they’re unable to do so.” AG013, which has been granted fast track designation by the FDA and orphan drug status in Europe, is currently in a Phase 2 trial in four countries. Oragenics expects to complete enrollment of 200 patients this fall, with topline data slated for early 2020. “Right now, there’s one product out in the marketplace but it’s only indicated for patients receiving high dose chemotherapy before they receive a bone marrow transplant, so it’s a very narrow indication. And as an IV, it has very limited opportunity for use in the much broader chemotherapy outpatient setting. That’s where a product like ours will be used,” Dr. Joslyn contends. While OM represents a significant unmet medical need and a potential global market that Dr. Joslyn estimates at nearly $1-billion, MDR infections remain one of public health’s biggest threats. According to the CDC, more than 2.5 million people in the U.S. get an MDR infection every year, and some 37,000 die. MDR Clostridium difficile is considered an urgent threat, with 500,000 infections causing 29,000 deaths per year, a fatality rate that has increased four-fold since 2000. Moreover, 8% of C. difficile infections present with another MDR infection, making treatment even more difficult. “A particular problem is that patients who develop recurrences of C. difficile infection are coming back on a relapse with a co-infection called vancomycin-resistant enterococcal infection, because vancomycin is one of the first-line treatments for C. difficile. This particular group of patients really is running out of treatment options,” he says. Oragenics is addressing this challenge by leveraging lantibiotics - antibiotics produced by bacteria to control their own microbiome. “Certain bacteria release tiny amounts of lantibiotics into their microbiome, which prevents other bacteria from encroaching on their space. The problem is if they make too much of this lantibiotic, it would kill the colony, so the bacteria have regulator genes that turn off production of the lantibiotic when the titer gets too high,” Dr. Joslyn explains. To produce sufficient amounts of lantibiotics, Oragenics licensed a technology that disables this regulatory gene from a company,Intrexon, which is now collaborating with Oragenics on its AG013 program as well. Oragenics then used this platform to create variants of a lantibiotic produced by Streptococcus mutans, and generated a library of more than 700 patent-protected, potential lantibiotics. “We’re now able to manufacture OG716 at a 1,500-liter scale and are accumulating the material required for our two toxicology programs. We’ll then transition to cGMP manufacturing for Phase 1 clinical trials, at the current scale,” he says. Oragenics is preparing to initiate preclinical toxicology studies of OG716 and expects to file an IND with the FDA in mid-2020. “We have a number of tremendously innovative programs where we’re able to manipulate bacteria and use those bacteria in a cost-effective manner as therapeutics, and within approximately six-to-eight months we’ll be reporting results from a significant clinical trial,” Dr. Joslyn says. • • • • •To connect with Oragenics, or any of the other companies featured on BioTuesdays, send us an email at editor@biotuesdays.com. via Features | BioTuesdays by Kilmer Lucas http://bit.ly/2MeeP3w Dr. Bill Williams, President and CEO BriaCell Therapeutics (TSXV:BCT; OTCQB:BCTXF) has reported impressive early safety and efficacy data with its lead immunotherapies for the treatment of advanced breast cancer. “Right now, there is no immunotherapy that works by itself against advanced breast cancer, an unmet medical need that was responsible for more than 40,000 deaths in the U.S. in each of 2017 and 2018,” Dr. Bill Williams, president and CEO, says in an interview with BioTuesdays. Immunotherapy is a type of cancer treatment that marshals the ability of the body’s immune cells to destroy cancerous tumors, with the advantage of fewer side effects than chemotherapy. BriaCell’s lead drug candidate, Bria-IMT, completed a Phase 1/2a clinical study in December, with “outstanding safety and efficacy data,” Dr. Williams contends. Bria-IMT is now in a Phase 1/2a combination study with Merck’s (NYSE:MRK) checkpoint inhibitor, KEYTRUDA, and has shown “excellent safety and evidence of additive or synergistic activity,” he adds. Dr. Williams says the company recently signed a clinical trial collaboration and supply agreement with Incyte (NASDAQ:INCY), which “will give us additional combination immunotherapies to try with Bria-IMT.” BriaCell also is developing Bria-OTS, an off-the-shelf personalized immunotherapy, with patients matched to one or two of 15 HLA (human leukocyte antigen) alleles based on a quick diagnostic test performed on human saliva. HLA typing, for example, is used to match donor and recipient to ensure the success of the organ transplantation. Personalized therapy without the need for personalized manufacturing “We have seen several remarkable responses in late-stage breast cancer patients who match Bria-IMT at certain HLA alleles,” Dr. Williams says, adding that this “supports development of Bria-OTS and a related diagnostic test, BriaDX.” Bria-IMT traces its roots to a breast cancer cell line called, SV-BR-1, developed by Dr. Charles Wiseman, a co-founder and inventor of most of the company’s intellectual property. He conducted the first proof-of-concept study with SV-BR-1 between 1999 and 2003. The study, with 14 late-stage, treatment-refractory breast cancer patients, demonstrated a median overall survival of 12.1 months, about twice what he was expecting, and no severe drug-related adverse events. According to Dr. Williams, SV-BR-1 was then genetically engineered to secrete granulocyte/macrophage-colony stimulating factor (GM-CSF), a monomeric glycoprotein which activates the immune system, effectively creating Bria-IMT. Dr. Wiseman conducted a second proof-of-concept study with one ovarian cancer and three breast cancer patients between 2004 and 2006, using a combination of Bria-IMT; cyclophosphamide, a chemotherapy; and interferon alpha. The study generated a median overall survival of 35 months, which was very impressive without serious side effects. Dr. Williams says one robust responder had a more than 90% tumor regression during treatment. When treatment halted, according to the FDA protocol, the patient relapsed, but then responded when treatment resumed. “This patient was the only one matching a key HLA allele with Bria-IMT and she experienced tumor regression and complete remission at some metastatic sites,” Dr. Williams points out. Dr. Williams, who joined BriaCell in late 2016, says Dr. Wiseman’s research funding ended after the second proof-of-concept study and little progress was made until the company was recapitalized during a reverse takeover earlier in the decade. In 2017, the company reinitiated treatment with the Bria-IMT regimen in an FDA-approved clinical trial with 23 advanced breast cancer patients. “We confirmed Bria-IMT’s mechanism of action and achieved proof of concept,” Dr. Williams contends. “Tumor regression was seen in patients who matched Bria-IMT at HLA loci, confirming our main hypothesis.” In the study, 21% of patients with one or more HLA matches had tumor shrinkage and 37% of patients had a biological response, which includes tumor shrinkage or lower circulating cancer-associated cells. In a subset of patients, with two or more HLA matches, 40% of patients had tumor shrinkage and 60% had a biological response. “One patient in the study had previously failed seven rounds of chemotherapy and had 20 lung metastases. She also had two HLA matches and after she was treated with a Bria-IMT regimen, her lung tumors either disappeared or shrunk to tiny scars,” Dr. Williams notes. In addition, Dr. Williams says BriaCell observed high levels of PD-L1 molecules on circulating cancer cells and cancer-associated cells in more than 90% of the patients. PD-L1 molecules block immune cells from attacking cancer cells. Checkpoint inhibitors, such as KEYTRUDA, are designed to neutralize PD-L1 induced immune suppression in cancer patients. “That’s why we believe there is a strong rationale of combining Bria-IMT, which increases an immune system response, with checkpoint inhibitors, which are designed to decrease suppression of the immune system,” Dr. Williams suggests. BriaCell is now in a Phase 1/2a study combining Bria-IMT and Merck’s checkpoint inhibitor, KEYTRUDA, in hopes of inducing a more potent anti-cancer response in advanced breast cancer patients. At the 2019 American Association for Cancer Research annual meeting in April, BriaCell reported initial findings from the first six heavily pretreated “salvage” patients enrolled in the Bria-IMT and KEYTRUDA combination study. Early evidence suggests “rapid additive or synergistic anti-tumor activity, including examples of tumor reduction at multiple sites and disease stabilization,” he notes. The combination also was safe and well tolerated. “While in earlier monotherapy studies, HLA matching between patients and Bria-IMT appeared to be important for the development of anti-cancer activity, we have seen some evidence suggesting that Bria-IMT in combination with KEYTRUDA may work for patients regardless of HLA matching,” Dr. Williams offers. The company expects to have additional study data to report at the San Antonio Breast Cancer Symposium in December. BriaCell also is advancing its combination thesis with additional compounds for advanced breast cancer under a clinical trial collaboration with Incyte. The companies hope to begin a Phase 1/2a study in the second half of 2019 with approximately 60 patients, and report safety and efficacy data by the end of 2020. Incyte plans to provide compounds from its development portfolio, including INCMGA0012, an anti-PD-1 monoclonal antibody similar to KEYTRUDA, and Incyte’s lead cancer immunotherapy candidate, epacadostat, an IDO1 inhibitor, to be used in combination with Bria-IMT. Hypothetical Mechanism of Targeted Immune Activation by Bria-IMT™ & Bria-OTS™ in Advanced Breast Cancer Dr. Williams says the company also is developing Bria-OTS cell lines to express both GM-CSF and interferon-alpha along with patient-specific matching HLA types. “Cell lines will be pre-manufactured, expressing HLA alleles and matching more than 99% of the overall advanced breast cancer population.” Using BriaDX’s companion diagnostic, he says the off-the-shelf alleles will be matched and selected for each patient prior to treatment. As a result, each patient would have a personalized mix and match of off-the-shelf alleles. “This has the potential to be personalized therapy without the need for personalized manufacturing.” Dr. Williams explains that the mechanism of action of Bria-IMT/Bria-OTS involves the production of breast cancer antigens. Bria-IMT/Bria-OTS further boosts the immune response by secreting the GM-CSF protein. “Breast cancer antigens are taken up by dendritic cells and presented to CD4+ and CD8+ T-cells implicated in tumor destruction,” he suggests. Bria-IMT/Bria-OTS also directly stimulates cancer-fighting CD4+ and CD8+ T-cells, further boosting the immune response, he adds. This unique mechanism sets Bria-IMT/Bria-OTS™ apart from similar immunotherapies. “Bria-IMT/Bria-OTS efficacy is enhanced when there is HLA matching of Bria-IMT/Bria-OTS with the patient. So, if the HLA type of a patient matches at least partially the HLA type of our cell line, we believe it is much more likely that the patient will experience a strong anti-tumor response.” The company hopes to receive FDA authorization to begin dosing patients with Bria-OTS at the end of 2019, and expects to report initial safety and efficacy data by the end of 2020. “These results should allow us to segue into a combination study with Bria-OTS and a checkpoint inhibitor, as informed by our results with Bria-IMT combination therapy, at the end of 2020.” “We anticipate that 2020 may be our value inflection point as we prepare for a registration study of Bria-IMT in combination with a checkpoint inhibitor,” Dr. Williams suggests. • • • • •To connect with BriaCell, or any of the other companies featured on BioTuesdays, send us an email at editor@biotuesdays.com. via Features | BioTuesdays by Kilmer Lucas http://bit.ly/2JZvpBv Michael Swartz, President MediXall Group (OTCQB:MDXL) has launched a new generation healthcare marketplace platform to address self-pay and high deductible consumers’ growing need for greater healthcare cost transparency and access to competitive pricing information. “Our platform makes scheduling an appointment for specific healthcare services as simple and easy as booking a flight and hotel,” Michael Swartz, president, says in an interview with BioTuesdays. “The online experience was designed to mirror e-commerce and online booking sites found in other markets: centered on providing consumers with ratings and reviews, transparent pricing, and comparative shopping,” he adds. Last November, the company launched its MediXall.com platform in Florida, with plans to expand nationally. The company also inked a strategic partnership with CoreChoice, a leading specialty network for diagnostic radiology, including MRI, CT, PET, X-rays, ultrasounds and mammograms. The accord provides MediXall with access to more than 22,000 fully credited radiology providers and facilities throughout all 50 states. “Once the existing network reaches its full dimension, the platform will include everything from dental to vision to cardiology, physical therapy, internal medicine and more,” he adds. Mr. Swartz explains that with MediXall.com, consumers are able to search and compare most medical, dental and wellness services based on all-in cash price; location and distance to the provider; ratings and availability; and select the best value according to their personal preferences. “In this era of rapidly increasing deductibles and healthcare costs, our cloud-based platform is designed to be transformational and disruptive to traditional methods of medical care and providing medical services to the consumer,” he contends. To use MediXall.com, a user books a service on the website with a credit card, which locks in the price but is not charged until the service is provided. MediXall.com sends the payment to the physician or lab and, in return, the company receives an administration fee of $15 from the transaction. “Through refinements of the pricing model, we have learned that we can make more than the $15 technology fee per appointment,” he adds. According to Mr. Swartz, surveys have shown that patients want to obtain pricing information for various treatments from their doctors, but doctors previously haven’t had a tool to help patients save money. As a result, the company recently launched the MediXall Patient Experience platform as a tool for physicians to share information about the cost and location of upcoming care options. “This system empowers patients to take control of their healthcare by showing options personalized for each self-pay and underinsured patient, how much it will cost, and more,” Mr. Swartz points out. “Gone are the days of unsupported patient searches for the right specialist or lab that accepts their insurance.” Mr. Swartz says MediXall.com’s plans for 2019 include ramping up MediXallRx, free tool that allows consumers to search and compare prescription drug prices and receive immediate savings of up to 80% with their MediXallRx Savings Card at the cash register for both generic and brand prescription medications. The card is accepted nationwide at more than 60,000 participating pharmacies, including Walgreens, CVS, Target, Walmart, and other national chains, as well as regional and local drugstores, he adds. The company also has partnered with a national lab company and “negotiated pricing” in order to launch a laboratory testing services program. “This new program will provide a seamless ordering experience for physicians to search, compare, and order affordable pre-curated panels or design custom lab test orders for their patients,” Mr. Swartz contends. With the recent appointment of Dr. Howard Braverman to its advisory board, MediXall is preparing for an expansion into eye care. Dr. Braverman is a former president of the American Optometric Association and was the national vision director for Humana’s Employer Group Segment. Mr. Swartz says Dr. Braverman is assisting the company with the critical areas of identifying and pursuing key strategies to help facilitate MediXall’s rollout into the vision space. MediXall also has entered initial negotiations that will facilitate adding additional in-demand medical and dental specialties on MediXall.com over the next three-to-six months. MediXall.com’s growth strategy involves expanding from its current base of Florida to major cities that have strong coverage with the CoreChoice network, Mr. Swartz says. “This would allow us to accelerate expansion and continue to increase our provider network with minimal effort and cost, focusing our resources on marketing to the consumer, and on technology development,” he adds. Beyond Florida, the company expects to expand to Texas, concentrating on four regions: Dallas-Fort Worth, Houston, San Antonio, Austin and El Paso. The strategy also anticipates expanding by using a West-Southwest strategy, focusing on New Mexico, Arizona, Washington State, Colorado, Oregon, and Nevada, as well as high-density areas in Pennsylvania, New York, Massachusetts, Delaware, Illinois, Ohio and Indiana. National Expansion Plan “We are still in the early stages of learning how to bring new value to our customers through the intertwining of consumer technology and healthcare,” Mr. Swartz says. “Our goal remains to solidify and extend our brand and customer base. This requires sustained investment in systems and infrastructure to support outstanding convenience, selection, and service while we grow.” • • • • •To connect with MediXall, or any of the other companies featured on BioTuesdays, send us an email at editor@biotuesdays.com. via Features | BioTuesdays by Kilmer Lucas http://bit.ly/2E8ixVV Gilles Gagnon, President and CEO Ceapro (TSXV:CZO) is transitioning to a new business model - from a contract manufacturer to a biopharmaceutical company - to pursue multiple growth opportunities in nutraceuticals and pharmaceuticals. “As part of our new product development, Ceapro will develop formulations potentially allowing delivery of bioactives through different modes of administration, including oral, topical, sub-lingual, and intranasal,” Gilles Gagnon, president and CEO, says in an interview with BioTuesdays. “We have industry leading extraction manufacturing processes to produce high value active ingredients from natural plant based sources, with a focus on oats,” he adds. “Our two value-driving active ingredients - beta glucan and avenanthramides – are used in multiple brand-name cosmetics and personal care products, and form the revenue generating base business in our personal care business.” These household brands include Aveeno, Jergens, Coppertone, Dove, Burt’s Bees, The Body Shop, Lubriderm, Nexcare, KY products and Neutrogena. Mr. Gagnon explains that beta glucan is a water-soluble fiber found in the cell wall of oat kernels that is highly effective in stimulating collagen synthesis. He says beta glucan’s key benefits include skin restructuring and wound healing; replenishing and protecting skin’s moisture barrier; reducing fine lines and wrinkles to decrease visible signs of aging; and potential reduction of bad cholesterol (LDL) and/or heart disease risk. “Ceapro was first company to demonstrate that beta glucan can be used as a delivery system because it can reach the dermal layer of skin,” he contends, referring to the layer of skin under the epidermis, which contains tough connective tissue. Avenanthramides are a group of polyphenol compounds found exclusively in oats. According to Mr. Gagnon, they contain antihistamine and anti-inflammatory properties that provide relief for a host of skin conditions, such as eczema, chicken pox and insect bites. Mr. Gagnon says that in cosmeceuticals, avenanthramides have demonstrated significant improvements in erythema symptoms in subjects with mild to moderate atopic dermatitis, or eczema. Johnson & Johnson, for example, has replaced cortisone with avenanthramides in one of its Aveeno line of skin care products, he adds. “Ceapro is the only company in the world producing the only commercial natural avenanthramide product,” he contends, adding that avenanthramides also have potential benefits in controlling inflammation-based disorders. Mr. Gagnon says Ceapro’s 2017 acquisition of the Juvente line of cosmeceuticals products was an “important step in our strategic market diversification business plan of moving closer to the customer.” Juvente utilizes Ceapro’s two active ingredients: beta glucan and avenanthramides. “While we are targeting several markets with Juvente to bring energy back to aging skin; repair structural skin components, especially for burn victims; and provide long lasting hydration to decrease fine lines and wrinkles while improving skin health, the Juvente line of products will mostly be used for the development of topical/transdermal delivery systems using Ceapro’s proprietary new chemical complexes, leveraging our game changing PGX technology, Mr. Gagnon offers. Ceapro’s initial foray into diversifying its business model includes developing a powder formulation of beta glucan plus an energy booster, co-enzyme Q10 (CoQ10), into a functional drink; a beta glucan formulation to reduce bad cholesterol (LDL) and/or the risk of heart disease; and an avenanthramide-based functional food to alleviate exercise-induced inflammation. Mr. Gagnon says the company has demonstrated the first water-soluble formulation of CoQ10 using its pressurized gas expanded (PGX) technology, a novel spray drying technique for processing water-soluble biopolymers. “The platform can produce numerous morphologies of biopolymers, ranging from fine fibers to granular powder, which are highly water soluble and stable,” he points out. The company has published results in peer-reviewed journals that confirmed the bioavailability of a water-soluble chemical complex of CoQ10 beta glucan, which differentiates itself from competing functional drinks. “All that remains is partnering, hopefully by the end of 2019 if we can get the right deal, to scale up production for sales,” he suggests. Mr. Gagnon says it is well known that people who eat oatmeal can reduce their bad cholesterol. Using the company PGX technology, he says Ceapro has designed high and medium molecular weight formulations of beta glucan. The first clinical study of the company’s potential cholesterol-lowering pill as an add-on therapy to cholesterol-lowering statins in subjects with hyperlipidemia now is recruiting patients at 11 sites in Canada as part of a collaboration with the Montreal Heart Institute. Mr. Gagnon explains that the study involves three sets of patients, with 66 treatment and 22 placebo subjects in each group, receiving three different doses of beta glucan. The primary endpoint of the 18-to 24-month double blind, placebo-controlled study is the change in LDL-cholesterol after 12 weeks. Ceapro and its collaborators at the University of Minnesota have demonstrated in bioavailability and bio-efficacy studies that low and high doses of avenanthramides can significantly reduce inflammation biomarkers in blood. Study results were presented at the 2018 American Society of Nutrition conference, with further data to be presented in a poster at the American Sports Medicine conference in Orlando in May 2019. Mr. Gagnon points out that in addition to PGX, the company’s enabling technologies include an ethanol-based extraction manufacturing process that can produce commercial scale quantities of active ingredients, and a proprietary drying technology to produce commercial scale quantities of pharma grade tablets of phenolic-based compounds. “Our strategy is focused on strengthening our base cosmeceuticals business and expanding into multiple growth markets,” he points out, adding that Ceapro’s enabling technologies have “broad utility in functional drinks, powders and pills.” Pipeline • • • • •To connect with Ceapro, or any of the other companies featured on BioTuesdays, send us an email at editor@biotuesdays.com. via Features | BioTuesdays by Kilmer Lucas http://bit.ly/2WyvJdW Michael Zilbershlag, Co-Founder and CEO Closely-held Leviticus Cardio of Israel is developing a wireless system capable of providing day-to-day power needs for implanted ventricular assist devices (VADs), eliminating the complications that congestive heart failure (CHF) patients face with existing VADs. “Our solution uses a unique proprietary technology called, coplanar energy transfer (CET), that has the potential to work with all available commercial VADs,” Michael Zilbershlag, co-founder and CEO, says in an interview with BioTuesdays. “VADs are increasingly in use to support patients with severe heart failure as an alternative for thousands of patients who are candidates for heart transplantation each year,” he adds. CHF is a common disease in the developed world, affecting some 23 million people worldwide. Of the six million people who suffer from CHF in the U.S., 250,000 have severe CHF, which has a low chance of survival and results in a very poor quality of life. The gold standard treatment for these patients is a heart transplant or treatment with a VAD. According to recent estimates from the National Institutes of Health, 50,000-to-100,000 patients in the U.S. are currently eligible for a VAD implant. Mechanical pumps now on the market are charged by a driveline power cord that protrudes from a patient’s abdomen and is connected to batteries or plugged into an electrical outlet. Patients must always have backup batteries on hand. “Driveline maintenance is a major quality of life issue for current VAD users,” Mr. Zilbershlag says. To prevent infection, patients undergo complex cleaning and dressing procedures to anchor the driveline. Mr. Zilbershlag explains that Leviticus Cardio’s technology uses a receiver inductive coil implanted in the body alongside a VAD, coupled with a battery and an internal controller. “An external coil, which is in a belt surroundings the chest for easy carrying, charges the inner coil electromagnetically,” he adds. In existing technology, to be successful, the transmitter and receiver must be aligned, so the energy is transferred through the small area of skin that separates them. In Leviticus’ technology, the transmitting is more robust, and the alignment isn’t an issue. The Leviticus battery lasts for around eight hours, after which the user needs to wear a vest for charging. A wrist monitor is used to keep track of the VAD, coupled with an internal vibration alarm that is triggered by a major hazard such as low battery power. The technology also includes a wire-based backup charging system that uses an internal power cable connected to the VAD. The cable passes under the neck skin and provides a skull-mounted "socket" behind the ear, Mr. Zilbershlag says, adding that the backup wire system will become a barrier for competition. System Components “Our wireless technology would allow patients to walk around without any physical impediments for up to eight hours a day, which represents a major leap in the quality of life for these severely ill patients,” he adds. “Our CET system also is an economically superior choice to external driveline systems, whose annual maintenance costs approach $20,000 per patient-year.” The company has 10 approved and four pending U.S. patents, covering wireless energy transfer into the human body and its related VAD implementations. There are an estimated 1.1 million people in the U.S. hospitalized annually with CHF, with hospitalizations growing 50% every five years, according to the American Heart Association. The available VAD market is some $14-billion a year. In February, Leviticus announced the first successful human implant on a compassionate basis of a fully implanted Jarvik Heart VAD with its CET powering system at the National Research Center for Cardiac Surgery in Astana, Kazakhstan. The procedure was published in the peer-reviewed Journal of Heart and Lung Transplantation. Mr. Zilbershlag says Leviticus plans to conduct an initial clinical trial with approximately 10 patients with the Jarvik pump before the end of 2019 and then seek an investigational device exemption (IDE) from the FDA. It plans to apply to the FDA to conduct an IDE study in the U.S. to collect data on the technology’s safety and efficacy in the second half of 2020. “In parallel, we will start development to incorporate our CET technology with any fully implanted VAD product,” Mr. Zilbershlag says, adding that the company plans to begin clinical studies with this second VAD at the start of 2022. “Our goal is to show that patients can expect an improved quality of life with Leviticus’ fully implanted VAD because they will be free from external equipment for many hours a day,” he contends. • • • • •To connect with Leviticus Cardio, or any of the other companies featured on BioTuesdays, send us an email at editor@biotuesdays.com. via Features | BioTuesdays by Kilmer Lucas http://bit.ly/2ZK89N7 Susan Linna, Managing Director Life Sciences As managing director, life sciences specialty services at BDO, the global professional services firm, Susan Linna has more than 25 years of drug, vaccine and biologic development experience, 13 of which were at a Fortune 100 pharmaceutical company, and 13 years in biotechnology. Ms. Linna started her career as a biostatistician and later took a leadership position building project management departments for biotechnology companies. She has led the creation of integrated product development plans, created joint plans for complex collaborations, and successfully managed these partnerships. She has also led teams to shepherd several product candidates successfully through development and obtain licensure through the FDA and other regulatory agencies. In this interview with BioTuesdays, Ms. Linna discusses the origin and expansion of BDO’s technical and operational life sciences services. When did you join BDO and what was the motivation? My route to BDO began with a strong relationship between Eric Sobota, national leader of BDO’s industry specialty services and life sciences practice, and his team at BDO. I was in the industry, and we worked with Eric’s team on multiple projects to assist with government proposals and financial compliance support for our government contracts funding research and development. Eric and his team helped my company secure more than $200-million in funding from the government and our relationship grew from there. I joined BDO in 2012, and Eric and I developed a plan to expand our team and technical consulting services. What are some of the life sciences services BDO provides? Our life sciences practice provides guidance to pharmaceutical, biotech, and medical device companies at every stage of a company’s lifecycle. If you are familiar with the standard metrics for this industry’s success rate, which can be around $2-billion in upfront costs before a product is approved, you recognize it is an extremely high-risk endeavor. Our main objective is to help our clients overcome technical or operational hurdles as quickly as possible to save time, reduce costs and successfully obtain product approval. Our services include product development support such as chemistry, manufacturing and controls (CMC), regulatory, project management, clinical operations, commercial strategy, product pricing and more. I believe BDO’s deep industry experience - now bolstered by the addition of BioProcess Technology Consultants (BPTC) - and commitment to client services set us apart from competitors. Can you describe project management services in life sciences? Project management is a skillset that integrates activities across all technical functional lines in the industry. It takes significant resources and support to discover, develop, license and commercialize a biopharmaceutical. The process from discovery to approval is typically an average of 10 years or more. The project manager’s job is to work with a team of technical specialists, scientists and MDs to formulate and execute on a project plan and timeline. Of course, product development is rarely predictable, so project management is also responsible for working with the team to develop and execute a risk management plan to minimize the impact of technical hurdles that result in timeline delays and added costs. Who is a typical BDO client? Our typical clients tend to be small-to medium-sized biotech companies that are developing large molecule products, such as monoclonal antibodies and vaccines. Some of the reasons they seek our support include limited in-house experience, financial resource constraints and a desire to pursue government funding to offset the high costs of late-stage development. Of course, not all clients fit this mold. Let’s talk about the expansion of BDO’s technical and operational life sciences services. On April 1, we acquired BPTC, a provider of CMC consulting and related services to the global biopharmaceutical industry. Joining forces with BPTC strengthens our ability to offer a broader range of services and to continue to assist life sciences companies in managing risk, maximizing profitability and fostering continued innovation to unlock new value and deliver improved outcomes. A total of 26 professionals from BPTC joined BDO, including 13 PhD’s, and Howard Levine, PhD founder, president and CEO. We’re so pleased to expand with a team of true industry leaders. How will the acquisition impact BDO? This acquisition will be extremely beneficial for our life sciences clients and for all internal BDO folks who work within the industry. The acquisition of BPTC allows us to provide a more comprehensive suite of services for clients to find the support they need to overcome challenges or to make necessary improvements to product development. BPTC has an experienced team adept at resolving technical challenges, assisting clients navigate regulations such as current good manufacturing practices, conducting cost of goods analyses and due diligence efforts, quality and regulatory compliance as well as many related aspects of producing biopharmaceuticals. BPTC has been rebranded at BDO as the BioProcess Technical Group (BPTG), and BDO will continue to offer specialized life sciences services through our life sciences consulting and government contracting groups. We believe BPTG will be an extraordinary practice and will open other doors for growth outside the U.S., as well. BPTG has clients around the world, including China, India and other countries where biopharmaceutical and drug manufacturing is done. Biotechnology is on the rise internationally, and we anticipate growth in several countries around the world that play a significant role in product development and manufacturing. When does a CMC group get involved with product development? Surprisingly, very early. Early process development activities initiate as soon as a company identifies a viable molecule that passes muster to enter preclinical development. The CMC group’s primary responsibility is to develop a process, analytical testing methods and all the associated activities to produce preclinical and clinical trial materials for investigative studies. As the product candidate advances in development, the CMC activities ramp up in parallel to develop more sophisticated and commercial scale processes and methods. In short, CMC is one of the most critical functions in the industry and they are engaged throughout the lifecycle of product development. Are there aspects of CMC that BDO might expand? We are always exploring new opportunities for growth. One of the more critical sub-specialties of CMC is regulatory compliance, which large pharmaceutical companies often have in-house. However, many small-and mid-sized biotech companies may not have the specific experience in-house that complements their product portfolio in development. Additionally, there is demand for regulatory experience in the industry, as navigating the regulatory pathway to FDA licensure can be complex. Another challenge for small-to mid-sized firms is that they typically rely on contract manufacturing organizations because they lack resources to build their own pilot plants and manufacturing facilities. This challenge applies to both biopharmaceutical products but also small molecule drugs and we view this as another opportunity for growth. Can you discuss BDO’s expansion planning in life sciences generally? There are several avenues for growth that are under discussion, but at this time, our focus is building strong relationships with our BPTG team and continuing stellar support for our current clients. We are very pleased to welcome a new team that has such critical experience and look forward to discovering creative ways to expand our services in the direction the market demands. • • • • •Connect with Susan Linna, or any of the other companies featured on BioTuesdays, send us an email at editor@biotuesdays.com. via Features | BioTuesdays by Kilmer Lucas http://bit.ly/2IAqy9Z Yesterday afternoon, Centric Health Corporation (TSX: CHH), a company focused on providing pharmacy and other healthcare services to Canadian seniors, issued an update on its recent medical cannabis initiatives.
During the first quarter of 2019, Centric Health continued the implementation of its medical cannabis strategy with Canopy Growth Corporation ("Canopy Growth"), its strategic partner. To date, Centric Health's clinical pharmacists have led several prescriber information evenings, as well as staff, resident and family education sessions, at long-term care and retirement homes. The Company's implementation plan remains on track and revenue generation has commenced through deliveries to the first 50 patients. Centric Health expects the adoption of medical cannabis to quickly accelerate as seniors, home care operators and medical practitioners continue to be educated on the benefits and uses of medical cannabis. As part of its commitment to offering seniors full clinical oversight of their medical cannabis needs, Centric Health announced that it has collaborated with Apollo Cannabis Clinics ("Apollo"), one of Canada's leading medical cannabis research organizations, to assist with virtual assessments of potential medical cannabis candidates. Apollo's clinical team of physicians, healthcare practitioners and support staff will assist seniors in Centric Health serviced homes in determining if medical cannabis is suitable for them, as well as prescribing products and providing ongoing monitoring for eligible candidates. Centric Health will also be participating in the upcoming Ontario Long-Term Care Association ("OLTCA") medical cannabis pilot study, which is being led by Canopy Growth. The OLTCA study aims to measure how medical cannabis use can potentially displace other, less-desirable treatments and therapies in long-term care residents. In addition to participating in the study some of its serviced homes, Centric Health will be providing insight to the OLTCA's Cannabis Advisory Committee on the role of pharmacies in supporting medical cannabis use in long-term care homes. "Centric Health's participation in the OLTCA study demonstrates our commitment to the clinical validation and pharmacy oversight of medical cannabis in seniors housing," said David Murphy, Centric Health's President and Chief Executive Officer. "We always strive to deliver the highest quality of care to seniors, and our strategic partnerships with Canopy Growth and Apollo will help increase medical oversight and reduce barriers to access for seniors who may be eligible candidates for medical cannabis." ABOUT CENTRIC HEALTH Centric Health's vision is to be the leading provider of pharmacy and other healthcare services to Canadian seniors. The Company is one of Canada's leading, and most trusted providers of comprehensive Specialty Pharmacy services and solutions to seniors. We operate a large national network of pharmacy fulfilment centres that deliver high-volume solutions for the cost-effective supply of chronic medication and other specialty clinical pharmacy services, serving more than 30,000 residents in over 450 seniors communities (long-term care, retirement homes, and assisted living facilities) nationally. With services that address the growing demand within the Canadian healthcare system, Centric Health's unparalleled national care delivery platform provides significant potential for future expansion and growth. FORWARD-LOOKING STATEMENTS This press release contains statements that may constitute "forward-looking statements" within the meaning of applicable Canadian securities legislation. These forward-looking statements include, among others, statements regarding the Company's business strategy, plans and other expectations, beliefs, goals, objectives, information and statements about possible future events. Forward-looking statements generally can be identified by the use of forward-looking terminology such as "may", "will", "expect", "intend", "estimate", "anticipate" or similar expressions suggesting future outcomes or events. Such forward-looking statements reflect management's current beliefs and are based on information currently available to management. Forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from those contemplated by such statements. Factors that could cause such differences include the Company's liquidity and capital requirements, government regulation and funding, the highly competitive nature of the Company's industry, reliance on contracts with key customers and other risk factors described from time to time in the reports and disclosure documents filed by the Company with Canadian securities regulatory agencies and commissions. These and other factors should be considered carefully and readers should not place undue reliance on the Company's forward-looking statements. As a result of the foregoing and other factors, no assurance can be given as to any such future results, levels of activity or achievements and neither the Company nor any other person assumes responsibility for the accuracy and completeness of these forward-looking statements. The factors underlying current expectations are dynamic and subject to change. SOURCE: Centric Health Corporation |
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