Perimeter pioneering high resolution wide-field tissue imaging for tumor specimens
Charles Carignan, CEO
Closely-held Perimeter Medical Imaging’s next-generation wide-field optical coherence tomography (OCT) technology for tumor tissue specimens has imaging resolution 10 times higher than ultrasound and 100 times higher than MRI.
“Our OTIS wide-field OCT captures significantly greater surface coverage than other commercial OCT systems,” Dr. Charles Carignan, CEO, says in an interview with BioTuesdays.
“OTIS is a micron resolution imaging device that provides real-time visualization of tissue microstructures of excised tissue specimens for surgery, pathology and radiology,” he adds.
Dr. Carignan explains that Perimeter’s technology is designed to image tissue specimens in real time after they have been removed from the body. “We’ve taken OCT technology and adapted it to quickly image very large surface areas of removed tissue. Think of it as a photocopier in that the tissue is placed on an imaging window and then scanned. With higher resolution than other scanning modalities, we can provide more detail at the time of a procedure to potentially obtain better clinical outcomes.”
Many surgical procedures rely on post-operative pathology information to avoid re-operating to remove additional tissue. Dr. Carignan points to one of Perimeter’s initial markets in breast cancer, where the breast lumpectomy market is plagued by 25% reoperation rates or higher.
“The surgical objective is to remove the tumor plus a healthy layer of surrounding normal tissue, normally several millimeters, as a proxy that no cancerous cells are left behind,” he adds. “Our solution has the potential to accurately assess microscopic disease during surgery to allow less tissue to be removed and minimizing changes to the cosmetic appearance of the breast.”
There are an estimated 760,000 lumpectomies performed worldwide annually. A study conducted by MD Anderson suggests there is a $16,000 cost increase for each lumpectomy reoperation, with a 49% increase in complication rates.
Perimeter’s platform device already has received 510(k) clearance from the FDA. Later this year, the company plans to submit its commercial device for FDA clearance, with an application for European approval in 2019.
The OTIS platform consists of four key components: a wide-field OCT imaging device; a single use consumable imaging window, which Dr. Carignan says represents a key revenue stream for the company; OTIS’ database of some one million breast tissue images and training programs; and machine learning image algorithms based its library of tissue structures.
The OTIS™ platform is comprised of 4 key components
While the Perimeter’s current focus is intra-operative tissue imaging, Dr. Carignan says that with the addition of biopsy/radiology and pathology, the company’s addressable market is at least $1.8-billion in the U.S., Canada, Europe, Japan, Australia and New Zealand, but excluding China.
Dr. Carignan, who moved into the executive suite at Perimeter at the beginning of June, has more than 20 years of experience in key leadership positions, spanning the medical imaging, women’s health, surgery and rehabilitation sectors. He says 25% of the Perimeter team worked together on previous breast imaging start ups.
“The OTIS optical tissue imaging system is poised to make a major impact on the tissue specimen imaging market,” he contends. “The team has done an incredible job developing OTIS and established strong clinical and strategic relationships that will be the basis for widespread adoption.”
Those relationships include MD Anderson Cancer Center, Harvard Medical School Teaching Hospital, Beth Israel Deaconess Medical Center, Memorial Sloan Kettering Cancer Center, Princess Margaret Cancer Centre, Mount Sinai Hospital, Columbia University Medical Center, and Carbone Cancer Center. Overseas, the company’s engaged with Agaplesion Markus Krankenhaus in Germany and the University of Edinburgh.
Perimeter and Mount Sinai currently are completing a study of the OTIS imaging system in head and neck cancer.
In an earlier 50-patient study presented at the American Society of Breast Surgeons in 2018, the company’s wide-field OCT demonstrated a 96% concordance with gold standard pathology.
And in a study of Perimeter’s screening programs, seven clinicians with limited training and without pre-operative information achieved 81% sensitivity and 89% specificity to assess post-lumpectomy breast tissue margins. “This gives us a great deal of comfort to commercialize our technology,” Dr. Carignan suggests.
The only margin assessment device currently on the market – Dune Medical’s Margin Probe – is a radio-frequency spectroscopy. “While we generate an image of a scan, Margin Probe is more of a sampling technique,” Dr. Carignan says, adding that Margin Probe has a much lower specificity than OTIS, is costly and has challenges assessing microscopic disease.
He also points out that there are florescence, MRI and probe-based optical imaging devices currently in development but these have not overcome high costs, low specificity and challenges assessing microscopic disease.
Dr. Carignan says Perimeter is planning a regional approach to commercialization, following regulatory approvals, targeting a broad range of tissue specimens including breast. The plan is to do a limited launch in the U.S. in late 2019 with a clinically focused direct sales team and channel partners to increase market coverage.
In 2020, the company expects to expand sales and marketing to Canada and the EU, using international distribution partners, followed by the rest of the world in 2021, with a specific focus on Australia, New Zealand and Japan, using qualified distributors.
Perimeter also hopes to raise up to $25-million USD, with funds earmarked to develop its next generation AI product, additional clinical studies and regulatory clearances, and building out its commercial infrastructure.
“We believe OTIS is a disruptive medical device platform that can save time and money for healthcare providers and fit easily into the clinical workflow,” Dr. Carignan says.
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Carl Firth, CEO
ASLAN Pharmaceuticals (NASDAQ:ASLN; TPEx:6497) expects to report topline and interim data in the second half of 2018 from up to four clinical trials with its lead drug candidate, varlitinib, for the treatment of biliary tract (BTC) and gastric cancers, and with ASLAN003 for the treatment of acute myeloid leukemia (AML).
“We have a development platform focusing on Asia-prevalent cancers that are orphan in the U.S. and Europe, allowing for a potentially faster route to market,” CEO, Carl Firth, says in an interview with BioTuesdays.
“Most of our clinical trials are run in Asia where a majority of patients live, but the data is leveraged to seek approvals in the U.S., EU and other global markets,” he adds.
For example, he points out that with a rare disease like AML, recruiting patients in the U.S. can be challenging because there are a lot of AML studies under way. In Asia, on the other hand, there are fewer AML studies underway, “so we feel we have a bit of an advantage recruiting patients,” he suggests.
“Asia offers a unique opportunity to accelerate development in diseases where the cancers are more prevalent, access to a larger population of patients is easier and more cost-effective, and there are fewer competing trials,” he adds.
In gastric cancer, for example, the Asia Pacific prevalence is one million patients a year, compared with 32,000 in the U.S. And in BTC, the Asia Pacific prevalence is 200,000 patients a year, compared with 12,600 in the U.S.
Singapore-based ASLAN has initiated a global Phase 2/3 trial of varlitinibin first-line HER1/HER2 gastric cancer patients, and expects to report topline Phase 2 data for overall response and tumor size from the first 40 patients in the second half of 2018.
Dr. Firth says that if the Phase 2 portion is successful, the company will proceed to the Phase 3 portion with 350 patients and a primary endpoint of overall survival. Both portions of the study are comparing varlitinib plus FOLFOX, a combination of chemotherapy drugs, against placebo plus FOLFOX.
In late 2018, ASLAN also expects to release interim Phase 1/2 data for varlitinib in first-line BTC and pivotal topline data in second-line BTC from a clinical trial in China. In addition, the company’s global pivotal TreeTopp (Treatment Opportunity with varlitinib in biliary tract cancer) study of varlitinib in second-line BTC expects to readout in 2019.
According to Dr. Firth, varlitinib alreadyhas demonstrated activity in BTC, gastric, breast and colorectal cancers, completing two Phase 2 trials, with more than 400 patients dosed. Across all clinical trials, the most common drug-related adverse events were fatigue, nausea and diarrhea.
In relapsed/refractory AML, ASLAN expects to post interim data in the second half of 2018 with its ASLAN003 drug candidate.
AML is a rapidly progressing blood cancer, which is characterized by uncontrolled proliferation of immature blast cells in the bone marrow. In earlier studies, ASLAN003 induced differentiation of AML blast cell lines, which has been linked with apoptosis, leading to normalization of AML bone marrow.
ASLAN003 is an orally active, potent inhibitor of DHODH
Dr. Firth contends that ASLAN003 has the potential to promote differentiation in multiple cell lines that are unresponsive to an existing first generation therapy, all-trans retinoic acid (ATRA), which differentiates blast cells in up to 15% of AML patients, with complete response rates of more than 90%.
In ASLAN’s Phase 2 study, AML mutation analysis and ex-vivo bone marrow differentiation will allow identification of patients that are sensitive to ASLAN003, he adds. The study has three cohorts of six patients each, receiving a different dose of ASLAN003. “When we find the most efficacious dose, we plan to expand the number of patients in that cohort to generate sufficient data to have a meaningful conversation with the FDA.”
Earlier this month, the company filed the equivalent of an IND in Singapore for a first-in-man study of ASLAN004 for the treatment of atopic dermatitis, the most common dermatological disease. “At some point, we will seek a partner for this product rather than continue development into pivotal studies,” Dr. Firth says, adding that the company’s focus will remain in oncology.
ASLAN recently hired Stephen Doyle as VP of commercial operations to begin building a commercial organization in China, where the company hopes to file a NDA for varlitinib in 2019. “We plan to build a similar commercial organization in the U.S. in the future,” he adds.
Dr. Firth explains that varlitinib is a highly potent, oral, small molecule with balanced inhibition across the HER family of receptors, targeting HER1, HER2, HER4 and, indirectly, HER3. The HER family is responsible for driving growth in human epithelial cells.
HER-selective drugs, such as Herceptin, target only one type of HER receptor, HER2. But blocking just one receptor type is ineffective for many patients, he points out, because these tumors may be driven by a combination of the HER family.
“Varlitinib has the potential to inhibit growth of a much broader range of tumors,” he contends. “Varlitinib is the only pan-HER product being developed for BTC and HER1/HER2 gastric cancer.” The drug candidate has received orphan drug designation from the FDA.
Among other things, varlitinib previously demonstrated a 60% response rate in a randomized second-line HER2 breast cancer study, which is “superior to standard of care,” he suggests.
Gastric cancer is the third highest cause of mortality worldwide. While the median overall survival rate in gastric cancer is about 11 months, Herceptin increases overall survival to almost 14 months. There are about 590,000 gastric cancer patients in China, compared with 32,000 in the U.S.
“We are targeting varlitinib to the 40% of gastric cancer patients that have HER1/HER2 co-expressing tumors,” Dr. Firth says, adding that these patients are currently being treated with doublet chemotherapy.
While BTC is often considered a subset of hepatocellular carcinoma (HCC), the most common type of primary liver cancer, Dr. Firth says drugs approved for HCC are not approved for BTC and median overall survival is about 12 months. Not a great deal is known about the drivers of BTC, he adds.
In addition, around 70% of BTCs express HER-family receptors and there are no approved targeted therapies for the disease. “Varlitinibhas the potential to be the first targeted therapy for BTC and first-line treatment for HER1/HER2 co-expressing gastric cancer,” he adds.
In an earlier Phase 1b clinical trial with 15 BTC patients, varlitinib in combination with doublet chemotherapy achieved an 87% disease control rate and 20% response rate. “All responders had a duration of response of at least 30 weeks and were controlled after patients discontinued doublet chemotherapy and continued on varlitinibmonotherapy,” Dr. Firth points out.
Following the Phase 1b study, ASLAN in April 2017 began its pivotal TreeTopp clinical trial with 120 second-line BTC patients at 58 sites in the U.S., Europe and throughout the Asia-Pacific region. The trial design includes randomizing patients with varlitinib in combination with capecitabine against placebo plus capecitabine, with topline data expected in 2019.
Dr. Firth says the trial needs to show a statistically significant difference in overall response or progression-free survival, but not necessarily both, “so we have two shots on goal.” The FDA also agreed that only 20% of the 120 patients must be from the U.S. and up to 80% from Asia, where the prevalence of BTC is higher. “Regulators have agreed that this study should be sufficient for approval,” he adds.
ASLAN also has a pivotal study underway in China with 68 second-line BTC patients. The first patient was enrolled in December 2017 and the company expects to release topline data by the end of 2018. The primary endpoint is overall response rate.
“Recent Chinese regulatory changes allow for the acceleration of innovative drugs addressing areas of high unmet need,” Dr. Firth points out, adding that in these cases, regulatory review averages seven months. “This could be the first potential path for varlitinib to reach market,” he suggests.
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Lior Margalit, Co-Founder and CEO
For the first time in a century, administration of epidural needles is being transformed with a smart device developed by closely-held Omeq Medical, which has completed a proof of concept (POC) preclinical study, is currently preparing for FDA submission, and expects to initiate first-in-human trials later this year.
“Our device integrates with standard syringe and needle kits to turn them into smart needles that alert physicians with visual indications once the needle penetrates into the right spot, and prevents overshooting into the spine,” Lior Margalit, co-founder and CEO, says in an interview with BioTuesdays.
A traditional epidural injection procedure involves the delivery of drugs such as anesthetics and steroids, into the four-millimeter space that contains fat cells and small blood vessels around the spinal cord, called the epidural space.
Epidural Space: Narrow and Hard to Find
The procedure requires extensive physician training and relies heavily on tactile feedback, and the loss of resistance (LOR) technique, in that once the needle passes through the ligaments of the spine and enters the epidural space, the physician feels a change in pressure that indicates the epidural space has been reached.
“When people think of epidurals, labor pain in pregnant women is what usually comes to mind,” Mr. Margalit points out. “In fact, globally each year most epidurals are used in surgical procedures by anesthesiologists, and in acute and chronic pain management.”
It is estimated that over 40 million epidural injections are administered annually throughout the world with inaccurate initial needle placement occurring in up to 30% of those cases, resulting in ineffective drug delivery, multiple insertions, and post-complications such as severe headaches, nerve damage and paralysis, he contends.
“Several years ago, when my father was undergoing orthopedic surgery the physician made three attempts at inserting the epidural needle,” Mr. Margalit recalls. “During one of those attempts, the physician punctured my father’s spine and, as a result, he suffered severe post-complications of headache, pain and nerve damage resulting in a lengthy hospital stay.”
As a biomedical engineer, this personal experience prompted Mr. Margalit to find a better way of administering epidural injections. “Clearly, there is a need for safer and more accurate epidural injections as the epidural space is narrow and hard to find leaving room for error, especially for younger physicians with less experience.”
The Omeq Medical smart device for epidural injections is a sensor-based, single-use epidural placement system for safe, accurate epidural injections, Mr. Margalit explains. “Our simple, easy-to-use device fits between a standard needle and syringe, and is compatible with most commonly used models on the market.”
The device gives automatic visual signals with LED lights that indicate correct needle placement, and continuously monitors tissue resistance at the needle tip, he says.
“In conjunction with LOR technique, a special blunted probe repeatedly protrudes from within the needle tip and monitors the resistance of the surrounding tissues to accurately detect, needle penetration into the epidural space,” Mr. Margalit describes.
Israel-based Omeq Medical has successfully completed a POC preclinical study at Assaf Harofe Hospital in Israel and is now moving toward clinical trials explains Mr. Margalit. “We are very encouraged by our POC results and are planning first-in-human clinical trials in Israel to commence by the end of 2018.”
With regard to FDA approval, Mr. Margalit says Omeq Medical is in the process of finalizing the file and plans to submit in a few weeks from now. “We anticipate FDA clearance in 2019.”
Results from the preclinical study will be part of the company’s FDA submission, he adds.
In addition to the potential for poor patient outcomes, multiple epidural insertions increase OR time and therefore, increase hospital costs because up to 30 minutes is generally required per epidural injection procedure.
In addition, Mr. Margalit points out that in the area of pain management, the current standard practise is to use image-guided, or x-ray machines, to accurately place epidural needles in order to administer a corticosteroid injection. “A physician may complete between 10-to-15 image guided procedures in a day, so exposure to radiation is a real issue,” he says.
Omeq Medical hopes to reduce the need for image-guided epidurals and in the future, plans to provide more clinical data in support of their device as a viable, safe alternative to image-guided epidurals, Mr. Margalit suggests.
“Our smart technology, assists physicians in giving safe and accurate epidural injections that result in improved time and cost efficiencies for hospitals, and most importantly, better patient outcomes,” he adds.
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Centurion BioPharma targeting strategic alliance for LADR drug conjugates by yearend
Eric Curtis, Centurion BioPharma CEO and President
Centurion BioPharma, a newly-created private subsidiary of CytRx (NASDAQ:CYTR), is currently in discussions with a number of pharma companies for a strategic alliance to continue development of its patient-identifying companion diagnostic and Linker-Activated Drug Release (LADR) anti-cancer drug candidates.
“More details on the companion diagnostic will become available in the weeks ahead,” Eric Curtis, Centurion BioPharma CEO and president, says in an interview with BioTuesdays.
“We believe that the companion diagnostic creates additional transformative potential,” he adds. “Our goal is to have a term sheet signed by this September and a deal closed by the end of the year,”
Mr. Curtis says a pharma partnership would determine the next steps for a pre-IND meeting with the FDA and filing an IND for first-in-human studies with the company’s LADR drug conjugates,” he points out.
“We are looking for a global partnership but would be open to regional alliances,” Mr. Curtis suggests, adding, “Our going assumption is that a pharma partner would license the companion diagnostic and all four of our LADR candidates.”
CytRx recently transferred its LADR assets into Centurion BioPharma as a vehicle to enhance its efforts to attract potential licensees and to focus on advancement of the companion diagnostic and LADR drug candidates.
Centurion BioPharma has preclinical data for four drug candidates: LADR-7, LADR-8, LADR-9 and LADR-10. All four candidates are eligible to advance into IND-enabling studies. The LADR platform has been studied in numerous solid tumor types, so “we think our platform has broad tumor potential,” Mr. Curtis contends.
LADR™ concentrates drug in the tumor and minimizes toxicity
He explains that the LADR technology uses serum albumin to transport the drug conjugate to the tumor, with a cleavable linker and ultra high potency drug payload attached. The linker keeps the drug payload inactive until the conjugate reaches the tumor, where it is cleaved off, activating the drug payload.
The LADR technology is designed to concentrate drug release at the tumor site, minimizing toxicity to surrounding tissue, compared with the parent molecule.
Albumin is a major source of amino acids and fuel for tumor cells. Mr. Curtis points out that an impaired tumor vasculature allows macromolecules like albumin to exit the bloodstream into the tumor microenvironment and ultimately be taken up into the tumor. “LADR conjugates exploit this feature of cancer biology to localize at the tumor.”
Enhanced Permeability and Retention (EPR) Effect
In April, CytRx presented three posters at the American Association for Cancer Research, featuring statistically significant preclinical efficacy data for the company’s four LADR drug candidates.
The posters highlighted positive scientific findings that led to CytRx’s decision to select auristatin E derivatives as the drug payload in LADR-7 and LADR-8, and maytansine derivatives as the payload in LADR-9 and LADR-10.
Auristatins are a highly potent cytotoxic family of peptides and to date, only one auristatin antibody drug conjugate, Adcetris, has been approved and marketed.
In a preclinical study comparing LADR-7 and LADR-8 with a control group or the parent auristatin, CytRx’s two drug conjugates demonstrated statistically significant antitumor activity, inducing long-term complete and partial responses in median relative tumor volume in all models including, melanoma, ovarian, non-small cell lung cancer, and head and neck cancers.
Maytansine inhibits proliferation of cancer cells, but its narrow therapeutic window prevents most clinical applications and to date, only one maytansinoid antibody, Kadcyla, has been approved for use in Herceptin-resistant breast cancer.
In a preclinical study comparing LADR-9 and LADR-10 with the parent maytansine, CytRx’s two drug conjugates demonstrated long-term partial and complete reductions in relative tumor volume in all cancer models studied, including lung, breast, ovarian, renal cell, and head and neck cancers. They also showed statistically significant superiority over the parent drug, maytansine.
According to Mr. Curtis, when paired with the companion diagnostic, LADR conjugates have competitive advantages, compared with antibody-drug conjugates, including broad therapeutic utility and patient populations, no narrow antibody receptor requirements, low risk of an immune response, low cost of goods and a simplified manufacturing process. LADR also has a “high probability of clinical and regulatory success,” he adds.
In May, H.C. Wainwright analyst, Raghuram Selvaraju, assumed coverage of CytRx, citing its two value drivers: the LADR platform and a license agreement with closely-held NantCell for aldoxorubicin, CytRx’s lead anti-cancer drug conjugate.
Mr. Selvaraju notes that the NantCell partnership connects CytRx to Dr. Patrick Soon-Shiong, who has had prior success in developing albumin-conjugated anti-cancer drugs. Dr. Soon-Shiong founded Abraxis BioScience, which took a drug very similar to aldoxorubicin, Abraxane, or albumin-bound paclitaxel, through clinical development and regulatory approval and was then acquired by Celgene for $3.5-billion in 2010.
In April, 2017, CytRx announced that the FDA agreed that CytRx could use the 505(b)(2) regulatory section when submitting a NDA for aldoxorubicin.
Under a July 2017 accord, NantCell is responsible for future development, manufacturing and commercialization of aldoxorubicin. CytRx is eligible to receive up to $343-million in potential milestones, with increasing double-digit royalties on sales of aldoxorubicin to treat soft tissue sarcomas and increasing single-digit royalties on sales for all other indications.
Mr. Curtis says NantCell is testing aldoxorubicin in combination with immunotherapies and cell-based treatments. Aldoxorubicin, an albumin-binding drug conjugate of doxorubicin, already has been tested in more than 600 cancer patients.
In January and February of 2018, NantCell began two Phase 1b/2 clinical trials with aldoxorubicin in metastatic pancreatic cancer and advanced squamous cell carcinoma of the head and neck or non-small cell lung cancer. At the end of last month, NantCell dosed the first patient in the Phase 1b portion of another Phase 1b/2 clinical trial for patients with triple negative breast cancer.
Last month, aldoxorubicin data, including its relevance in the future treatment of soft tissue sarcoma, was published in the peer-reviewed journal, Future Oncology.
The paper notes that aldoxorubicin was principally developed to increase efficacy and overcome the cardiotoxic side effects of the anthracycline agent, doxorubicin. CytRx’s earlier studies with aldoxorubicin demonstrated increased progression-free survival and tumor response, with tolerable side effects.
The authors conclude that the unique biochemical structure of aldoxorubicin causes its target-specific drug delivery property, which, in combination with its negligible levels of cardiotoxicity even at high doses, should give aldoxorubicin a “meaningful role in the treatment of patients with metastatic soft tissue sarcoma, as an adjuvant therapy in sarcomas, or as a treatment for patients who have other anthracycline sensitive tumor types.”
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Armen Bakirtzian, Co-Founder and CEO
Closely-held Intellijoint Surgical plans to improve patients’ lives by providing every orthopaedic surgeon with their surgical 3D solution that provides real-time intraoperative measurements to ensure accurate size selection and positioning of artificial implants during total hip arthroplasty (THA), which involves replacement of the damaged portion of the hip with artificial components.
“The sky’s the limit for our core technology developed in anticipation of multiple products tailored to specific workflows, but our first focus has been on our flagship product, intellijoint HIP, custom built for hip surgery,” Armen Bakirtzian, co-founder and CEO, says in an interview with BioTuesdays.
Traditionally, orthopaedic surgeons are equipped with preoperative images of the patient’s hip to help them plan what they would like to achieve in the THA. Important targets, such as leg length, offset, or the distance of the leg from the midline of the body, and even orientation of the implantable cup, are set preoperatively.
“The downside is that these preoperative images are only useful in helping to create a preoperative plan, not execute it,” Mr. Bakirtzian contends. “As a result, up to 62% of cups are not placed within a predetermined target range, and up to 49% of all unassisted THA result in leg length discrepancy of more than 5 mm.”
According to Mr. Bakirtzian, with intellijoint HIP, a miniaturized, surgeon-controlled, 3D optical navigation camera and tracker, surgeons are provided with real-time, intraoperative measurements to assist in proper sizing and placement of the implant. With these quantitative measurements, “the device then helps align the implant in the desired location without having to rely on pre-operative imaging so cup position, leg length, offset, and hip centre of rotation are accurately determined,” he adds.
With regulatory approval in U.S., Australia, Europe and Canada, intellijoint HIP is indicated for anterior, posterior and lateral approaches in both primary and revision THA, he says.
“In only eight years we’ve moved from a small start-up to a fully commercialized scale up with over 5,000 THA cases completed in top orthopaedic hospitals throughout the world,” Mr. Bakirtzian explains. “Our plan in the near future is to expand our core technology into other areas such as knee arthroplasty.”
The Intellijoint Surgical core technology uses a combination of hardware and software and integrates miniature optical sensors with tailored software packages to offer seamless integration into any standard surgical workflow and is compatible with every major implant vendor, he adds.
“Our device takes the guesswork out,” Mr. Bakirtzian points out. “Surgeons no longer have to eyeball hip implant positioning, minimizing risks that can include joint instability resulting in dislocation, leg length discrepancy, and revision surgery later.”
As the story goes, intellijoint HIP is the result of a conversation between Mr. Bakirtzian and his orthopaedic surgeon father who voiced frustration with current navigation systems that violated key criteria important to orthopedic surgeons such as speed, ease of use, and integration with workflow.
“It was originally a final year university design project,” Mr. Bakirtzian says, who then pitched the intellijoint HIP idea at the 2010 Next Top Young Entrepreneur Start-Up Pitch Competition, along with colleagues Richard Fanson and Andre Hladio. “After winning the competition we co-founded Intellijoint Surgical and began the journey to commercialize our flagship product.”
Currently, there are 1.2 million THA procedures performed in Canada, U.S. and EU annually. Hip replacement surgery generally leads to positive results. However, dissatisfaction occurs in between 15% and 30% of patients, with the most common complaint being that legs are different lengths.
“With other computer assisted navigation systems, between 1.5% and 3% of THA require revision surgery with readmissions usually within 90 days of primary surgery,” Mr. Bakirtzian says.
“There are other image-based navigation technologies out there, but they are not suitable for revision THA,” Mr. Bakirtzian says. “The other systems rely on pre-operative imaging, but that can result in significant inaccuracies because the image can be distorted by metal from existing components placed during primary surgery.”
“Up to 8.9% of patients will be readmitted within 90 days with most readmissions due to instability and dislocations,” he adds.
“Our sophisticated, yet simple smart tool is the only 3D mini-optical navigation solution cleared for both primary and revision THA,” Mr. Bakirtzian says. “It can reduce the risk of revisions because it provides accurate information down to the millimeter, so surgeons can make the right decisions for each individual patient, intraoperatively.”
Using the intellijoint HIP device only adds approximately three minutes to the surgery time, he explains.
“We’ve been able to address the shortcomings of traditional navigation with a solution that has a short learning curve, and that offers hospitals a low risk, no up-front investment, pay as you go model that provides the patient with the very best possible outcome in orthopaedic surgery,” he adds.
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