An Interview with BioSyntech's CEO, Claude LeDuc
BY JOHN MCCORMICK, APRIL 18, 2005
Claude LeDuc, CEO Biosyntech
Last week we interviewed Claude LeDuc, President and Chief Executive Officer of BioSyntech, a Canadian developer of thermosensitive gels that address articular cartilage repair and other clinical needs.
JM: Introduce our readers to BST-Gel™ and why its properties matter to orthopedics.
CL: BST-Gel™, our platform technology, is based on a natural biopolymer originating from crustacean shells, called chitosan. This abundant material has been shown in the scientific literature to have many positive tissue repair properties. The BST-Gel™ family of hydrogels is liquid at low temperature and solid at human body temperature- making BST-Gel™ injectable to specific sites where it solidifies, offering therapeutic properties for the local repair of damaged tissue such as cartilage, bone and chronic wounds. The unique ability to gel at body temperature offers the key benefit of avoiding invasive surgery. Of course, BST-Gel™ is biocompatible, muco-adhesive and safely biodegradable.
JM: What areas have you used BST-Gel™ to develop products?
CL: From the BST-Gel™ technology, we are presently developing several therapeutic areas in orthopaedics including Cartilage and menisci Repair with BST-CarGel™, and BST-Ossifil™ for Bone Repair and Therapeutic delivery using Calcium Phosphate and BMPs. In addition, we are using a fatty acid formulation called BST-InPod™ for the Treatment of Heal pain through plantar fat pad tissue augmentation.
JM: Tell us more about BST-CarGel™ because many of our readers are interested in articular cartilage repair.
CL: There is a large unmet medical need for effective cartilage repair technologies. Adult articular cartilage does not have the capacity to repair structural damage resulting from injury or disease. This limited healing potential arises primarily due to a lack of blood supply and an appropriate level of repair cells. The resulting joint pain and loss of mobility is debilitating for millions of people worldwide.
In many cases, treatment of either acute or chronic focal cartilage injuries involves use of various surgical measures aimed at regenerating tissue in the damaged area, including bone marrow stimulation, mosaicplasty and autologous chondrocyte implantation, each with inherent drawbacks.
We believe that BST-CarGel™ is a promising new therapeutic approach for repair of localized cartilage lesions. BST-CarGel™ is mixed at the time of surgery with the patients own blood and applied during minimally-invasive surgery to the surgically prepared lesion.
Our pre-clinical studies have shown that BST-CarGel™ fills the cartilage lesion, where it acts as a 3-dimensional scaffold in what is called Scaffold-Guided Regenerative Medicine (SGRM). Due to the chitosan component and its unique tissue-adhesive nature, the residency of BST-CarGel™ is maintained. And because the repair of the cartilage occurs within the body, and not in a laboratory, it is termed In Situ ChondroInduction (ICI). During the regeneration process, our animal studies have demonstrated that BST-CarGel™ is completely and safely degraded, resulting in dramatically improved cartilage repair.
JM: Where is BST-CarGel™ in its clinical testing?
CL: Our clinical focus right now for BST-CarGel™ is on a 12-month Canadian-European pivotal trial we have set up and hope to initiate in late Spring, 2005. This trial will permit licensing in Canada and Europe, in addition to supporting FDA submissions. We are currently in pre-IDE discussions with FDA to prepare for a US study. Our current clinical knowledge is based on 33 patients who have been treated with BST-CarGel™ in Canada under the surgeon-initiated Special Access Programme for medical devices based on compassionate grounds.
JM: Is cartilage repair disruptive to big hip and knee players?
CL: There will always be a need for metal and plastic prostheses for the aging population. However, we believe BST-CarGel™ will fill a large gap in current treatment algorithms containing millions of patients who are not yet candidates for prostheses- and where surgeons run out of non-surgical options. It is difficult to predict whether or not successful cartilage repair carried out on younger patients will cut into the prosthetic market.
JM: What is the competition like for you in the cartilage repair space?
CL: From a product standpoint, there is only one marketed product for cartilage repair in the US and it is an expensive, complicated cell based therapy. Other than that, the competition is the surgeon himself, who has a number of techniques purported to offer some pain relief, albeit with a lack of true cartilage repair (bone marrow stimulation, mosaicplasty). We believe we stand alone with SGRM and BST-CarGel™, which does not require cartilage cells and is extremely surgeon friendly.
JM: What other things do you have going on in R&D that relate to orthopaedics?
CL: As I mentioned, BST- Ossifil™ is in development for bone repair, with added capabilities in delivery of BMPs. We are also exploring the use of our platform technology in intervertebral disc repair using BST-Disc™. Also, in parallel with BST-CarGel™ development, our Instrumentation division has developed a very unique arthroscopic probe which can non-destructively detect the quality of cartilage.
JM: Does Biosyntech do its own manufacturing? How extensive are your lab facilities?
CL: Currently, Biosyntech manufactures all of our products in-house. Our facilities are equipped for compounding and filling, and registered to ISO 13485. As an interesting side note, we have accumulated significant know-how in the purification and characterization of chitosan, which we have begun to sell as Ultrasan™. This is the highest medical grade chitosan available on the market.
We have a 20,000 sq. ft. state-of-the-art facility, which houses our research and development laboratories, manufacturing facilities, and corporate offices.
JM: Do you get much attention from US partners being a Canadian company?
CL: As you can imagine, with our comprehensive IP portfolio and with 3 products about to start clinical testing, there is quite an interest in our company as a whole. For confidentiality reasons we cannot disclose much, but we can say that we are in late-stage discussions with two US orthopaedic leaders for licensing and/or distribution agreements, in addition to various other discussions with related groups. We are reaching globally with our objectives, and have not allowed our location to impact our strategic capabilities.
JM: What kind of revenue outlook are for Biosyntech are you sharing with investors?
CL: Our revenue source will be mainly derived from our distributors transfer price starting end of 2006 (inventory building) from BST-DermOn™ (wound healing) and later in 2007 for both BST-InPod™ (heal Pain) and CarGel in Canada and Europe. Revenues from the US market should start in 2007 from BST-DermOn™, in 2008 from BST-InPod™ and 2009 from BST-CarGel™.
We may breakeven the first revenue year as our burn rate is very low and controllable and we are carrying very little debt.
JM: Any other thoughts?
CL: To steal a line from a 2004 Technology Review Issue editorial on Innovation: "The real bottleneck isn't invention; It's the inability to cost-effectively translate breakthrough inventions into marketable products" BioSyntech's BST-Gel™ technology and products perfectly fits this "Innovation" definition as BST will offer cost-effective answers to unmet medical needs which means affordability to world health systems and ultimately to patients.
