Cartilage Repair Comes of Age: An Interview with Gerald 'Gary' Bisbee, CEO of ReGen Biologics, Inc.
BY JOHN MCCORMICK, OCTOBER 25, 2004
Cartilage repair is coming of age. One of the leaders in this emerging technology is ReGen Biologics. During the recent HealthpointCapital Biologics Summit, we spent a few quality moments interviewing Gary Bisbee, CEO of ReGen Biologics.
JM: Introduce our Readers to your core product - the Collagen Meniscus Implant (CMI).
GB: The CMI-Collagen Meniscus Implant, is actually the first product from a proprietary technology that ReGen Biologics developed over the last decade. That technology is well protected and we have more than 20 patents surrounding it for both the use of the CMI in the meniscus as well as the biological material. The CMI was developed to serve a market of 1 million people in the U.S. annually who have part of their meniscus removed. The reason that removal of the meniscus becomes an important lifestyle issue is because the meniscus acts as a buffer in the knee between the shin and thigh bone. If part of the meniscus is removed, then that buffer is removed and osteoarthritis sets in, which increases pain and reduces activity.
JM: So CMI essentially deals with pain...
GB: That's right. Meniscal loss actually causes an interrelated reaction between pain and activity level. The more pain, the less activity.
JM: Tell us about CMIs implanted to date. What are the outcomes? In what countries?
GB: The product has been approved for several years in Europe, Australia and Chile. We are hoping for a limited approval in Canada next year. Both surgeons and patients have accepted CMI. In Europe, each country is reimbursed on a unique basis. There are some differences in use of the CMI depending on whether that country has approved a reimbursement. Bottom-line: we have promising results in Europe. The clinical outcomes from use of the CMI are best measured by our clinical trials, however. In Europe, they have not collected outcome information. The CMI clinical story is excellent, the product is safe, the tissue grows in substantial volume and activity levels are up.
JM: Are CMIs unambiguously better than accepted practice?
GB: Definitely better, accepted practice is a partial meniscectomy procedure, where part of the meniscus is removed, which can lead to osteoarthritis. When the CMI is implanted, we have documented in our U.S. clinical trial that the tissue growth, post-implant, doubles. Think about the stress forces of your knee for a minute' they can be 10X your body weight depending on activity levels. Having twice as much meniscus/buffer post-implant is a strong positive.
JM: Has enough time passed to determine if CMI prevents re-ops of partial meniscectomies in a meaningful way?
GB:That's a good question John, and as you know this is a question that be-devils orthopedics. Surgeons think in five-year blocks. From a company standpoint, it's tough to follow these products for that long. What we do know is we have a feasibility study that included eight patients. These patients allowed the surgeon to conduct an arthroscopic re-look procedure at six years.
JM: That's impressive.
GB: It was also impressive that the tissue was as viable in six years as it was in one year. This has been reported in an article that has been accepted for an upcoming issue of the Journal of Arthroscopy, which is expected to be published in the next six months. It will report that not only has the tissue remained constant over that time, but the patient activity level has increased.
JM: How does CMI regenerate tissue (volume gain)?
GB: The volume gain for a CMI patient is about twice what the patient had post partial meniscectomy [75% vs. 38%]. The mechanism for growth is that the collagen scaffold is sutured in the meniscal rim and receives blood supply from the meniscal rim. Also, the cells of the synovial fluid help facilitate tissue growth. After several months, the implant is absorbed and the patient is left with his or her own generated tissue.
JM: What reactions are you getting from doctors?
GB: In the U.S., 23 surgeons have participated in the U.S. clinical trial and they were quite positive about it. We had a number of surgeons that put in 20-30 of these in the U.S. clinical trial and were obviously sold on it. In Europe, there is a core group of interested surgeons that are implanting. One surgeon in Italy has implanted 40 CMIs and another in Germany has implanted 10-15. The actual procedure time is not materially different from the partial meniscectomy, which is probably 30-40 minutes. The CMI average is 90 minutes. The surgeons don't view that as a material difference.
JM: How about patients?
GB: Patients that we come in contact with are quite positive. We enrolled a number of patients for our clinical trial, a number were turned away for various reasons. Just judging by the demand factor, we think - assuming the FDA approves this product - tHere's going to be substantial patient demand.
JM: Any suggested follow up reading?
GB: When our article is published in the Journal of Arthroscopy that will be interesting reading. There's also a bibliography of articles that appear on our website, www.regenbio.com . I encourage any interested readers to go to the website and check out our PowerPoint presentation, which has data on volume growth and patient activity scores.
JM: For our readers, summarize the different modules of your modular PMA application.
GB: There are three modules. We requested from the FDA the opportunity to undertake a modular submission and they agreed. The first module is the manufacturing module and that has already been submitted. We've received comments back from the FDA and there were no show stoppers there. We're in the process of responding right now. The pre-clinical module (which is more administrative and policy oriented) will be submitted during Q4 of this year. We expect to submit the clinical module in Q1/Q2 of 2005 - I would think early Q2:05. And let me add that, typically, once the clinical module has been accepted by the FDA ('filing') we expect that 12-16 months later, we would find out where we are at on the approval side.
JM: If all goes according to plan, are you comfortable estimating an FDA approval date?
GB: Of course this depends on when we do submit. We do think that we will be able to submit Q1/Q2 of 2005, most likely early Q2. Then it depends on how the FDA looks at this and when the FDA staff reviews the application. Without trying to pre-empt the prerogatives of the FDA, I'd say you can typically count on consideration in a 12 to 16 month timeframe.
JM: If the PMA only involves medial meniscus is there a separate PMA required for lateral meniscus?
GB: That's a good question and the answer appears to be yes - there is a separate PMA required for lateral. We do intend to introduce the lateral product in Europe probably in early 2005. It is also our hope that, assuming the medial is approved by the FDA, that the FDA will work with us to design a trial that is appropriate for the lateral CMI given the fact that we will have a tremendous amount of data on the safety issues. That might allow us to do a quicker or smaller trial in the U.S. But our market projections for the next four to five years do not include any laterals.
JM: On the happy day you receive the PMA, what is your rollout plan?
GB: I'm sure management will be working overtime at that point. (laughter) We have two options: One is to sign an agreement with a global distributor to distribute the product both in the U.S. and globally. Two would be that we might choose to market the product ourselves through a network of independent distributors. We have to make that decision, and management is studying that right now. We are engaged with our board to discuss this. I would guess that in Q2:05 of next year we'll make a decision about which path to pursue.
JM: Given your April $10 million financing, do you feel that you have the cash you need to get the FDA panel meeting (Q4:05/Q1:06) without further fundings? Through an anticipated FDA approval?
GB: We do have enough cash to get through these events. In terms of increasing our marketing in Europe and preparing to market in the U.S. and conducting continued R&D, may be advisable to conduct another round, which we are thinking about for early 2005.
JM: What R&D projects other than CMI are you undertaking?
GB: We have a product for the spine using our core technology. We have a product for articular cartilage. When I say product, I mean product in early R & D. Those two products have the potential to be very large. There are a variety of other products in our pipeline that will target niche markets. By the way, on reimbursement for the CMI in the U.S., it looks like we'll be able to piggy back on the CPT code for the meniscus transplant, the RVU there is very favorable. So the reimbursement that we've been working on for two years is looking very favorable at this point.
JM: Thank you for your time Gary.
GB: Thank you John.
