Fibralign Corporation is a Stanford spin-out that produces advanced therapeutic biomedical devices utilizing its patented Nanoweave™ technology for fabricating 3D scaffolding which precisely mimics human tissue structure.
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AngelMD had a chance to talk to Fibralign’s CEO, Greg King, and learn more about their important work. We hope you enjoy this conversation. If you’d like to know more about this exciting angelMD company, please visit this link to be included in exclusive communications.
Can you tell us more about BioBridge?
The BioBridge™ Collagen Matrix is a thread-like scaffold made of highly purified collagen which has been shown to promote and direct new vessel formation (angiogenesis and lymphangiogenisis). The product that took over three years to develop in collaboration with Stanford and received 510(k) clearance last year for use as a surgical mesh for soft tissue repair. We are completing an initial “first-in- women” clinical study in the Dominican Republic treating patients with breast cancer related lymphedema and are about to start a larger clinical study with Stanford. The Stanford study will be applied to expand the 510(k) indication for use of BioBridge to include lymphatic tissue and provide data for marketing for this treatment.
For those less familiar with secondary lymphedema and its current therapies, can you discuss why this is an important target?
We chose lymphedema for BioBridge’s first focus because it is truly a large unmet need with no cure. Secondary lymphedema develops when the lymphatic system is disrupted and unable to transport interstitial large fluid away from a region of the body. It is characterized by gross swelling of the affected limb accompanied by fibrosis, resulting in serious infections (cellulitis and skin ulcers) and can lead to severe deformity, and even amputation. Secondary lymphedema in western countries most commonly occurs as a delayed result of cancer treatment, particularly in breast cancer patients where an estimated 15-30% of patients are impacted. Metastatic tumor cells can frequently spread via the lymphatic vascular system and colonize lymph nodes, necessitating radical surgery that often destroys lymphatic vessel networks and impairs lymph drainage.
Conventional therapies (compression garments, physical therapy, massage, etc.) that are commonly used can be helpful in reducing discomfort, but treat only symptoms. These therapies are time consuming, provide limited relief and are costly — mostly paid for out of pocket. Since they require great persistence, often with diminishing returns over time, many patients give up in frustration and stop treatments. Surgical procedures have been more recently deployed as part of reconstruction surgery, but with limited success, relegating most patients to conventional therapies.
How is BioBridge different than other proposed therapies for treating secondary lymphedema?
BioBridge will be used to support surgical intervention of lymphedema by providing soft tissue support that allows for restoration of lymphatic function. BioBridge is a medical device that has been designed to be implanted subcutaneously in the diseased area as a temporary scaffold and, since it is made from purified medical-grade atelocollagen (without any additives), made to safely resorb in 6-9 months.
Based on our engagement with KOLs in this field, we anticipate that BioBridge will be used in different surgical approaches by oncologists and plastic surgeons to both treat and prevent secondary lymphedema. The clinical study with Stanford will be evaluating the therapeutic effect of BioBridge as an adjunct to autologous lymph node transfer (ALNT). ALNT surgery is a microsurgical procedure that has grown recently in popularity where a patient’s healthy redundant lymph node is transplanted as a free flap to the diseased area. Transplantation of healthy tissues, to reverse the loss of lymphoid tissue and function, has shown some improvement in limb edema with evidence of lymphatic re-routing and clinical evidence of spontaneous lymphatic regeneration. Although this procedure has been shown to provide some benefit in human lymphedema patients, autologously transplanted lymph nodes incorporate into existing lymphatic vasculature at a low frequency and failure of the transplant to integrate into existing lymphatics compromises the outcome. It is expected that BioBridge will address a fundamental weakness in this procedure and substantially improve surgical outcomes to make this an effective treatment for patients.
What other applications are there for the patented Nanoweave™ technology and what advantages will you offer in those markets?
While our primary commercial focus is making BioBridge successful for treating lymphedema, we are developing a pipeline of other circulatory disease applications (peripheral artery disease, CLI, myocardial infarction), nerve repair/regeneration and as a novel drug/cell delivery device. BioBridge provides the opportunity to address these chronic diseases Current treatment options available for these chronic diseases are lacking and Fibralign’s approach provides the means to promote and direct regeneration to repair tissue (angiogenesis, arteriogenisis).
BioBridge’s capabilities can also bring significant value to delivery applications by increasing cell survival, localizing delivery, improving efficiency and enhancing the regenerative process. Through our collaboration with Stanford we have demonstrated that BioBridge provides a 3D structural template that provides instructive cues to enhance cell survival, proliferation and differentiation. We have also been working with Stanford and the VA on a DoD-funded project to use BioBridge as a solid state delivery device for gene therapy (HGF mmRNA) that will be used for muscle loss/repair and vascular regeneration. Regulatory approval cycles are expected to be more involved for such combination devices but are expected to provide substantial follow-on opportunities.
What third-party validation have you received from the scientific community?
The Company has collaborated with leading researchers (Stanford, UCSF, others) that has resulted in published pre-clinical studies which validated BioBridge and the Nanoweave technology for regenerative medical applications. These efforts included successfully completed a six-month translational large animal lymphedema study with Stanford (DoD funded) that demonstrated the efficacy and safety of BioBridge. This published study, the first of its kind, showed definitively that BioBridge promoted formation of new functional lymphatic vessels and restored lymphatic function. The published study results showed definitively that in animals with lymphedema, implantation of BioBridge (1) normalized or reduced the extracellular liquid volume and (2) increased the number of functional lymphatic collectors, which was accompanied by (3) BioBridge integration into irradiated tissue and (4) formation of new microvasculature with increased lymphatic fraction in the proximity of the scaffold.
Fibralign is also carefully evaluating other future product opportunities that would benefit greatly from its core Nanoweave™ technology. The Company has engaged in select development projects with industry and university collaborators that are expected to result in forward commercial products.
What interest in Fibralign have you had from industry?
Fibralign has attracted strong interest and support from KOLs in this field, including clinicians, oncologists and microsurgeons, as well as from patient groups and national and international lymphedema organizations. The Company have been engaged with KOLs and participated in lymphedema-related medical and scientific conferences over the past three years and have interest generated throughout the US, Europe, Japan, China, Taiwan, Russia and India.
Industry partnering is an important strategy for both advancing commercial engagement and for licensing our core technology for other applications. However, at this stage, we are mainly focused on our initial product. But we have maintained ongoing select and funded development programs with industry and currently in discussions with a large medtech company about a potential strategic relationship. We certainly plan to engage others going forward.
How do you think syndicating an investment with angelMD will benefit Fibralign?
angelMD provides a unique opportunity to engage medical professionals who can appreciate the potential of Fibralign’s core technology in helping to address unmet medical needs and provide value beyond the investment. We are excited about engaging members of the network in ways that will help us build a successful company and provide guidance in developing a pipeline of opportunities in other specialties, such as orthopedics.
Tell us about your team and their unique capability in this specific field.
Fibralign has assembled a strong, multi-discipline, cross-functional team that consist of eight full-time and seven part-time members whose deep experience span across biotech, engineering, materials science, operations, process development and market/business development. Team members have worked in relevant biotech GLP/GMP commercial enterprises, spanning process development (Collagen Corp.), biomedical engineering, product development and QA/QC (J&J DePuy Synthes).
Consultants have been engaged to bring special industry skill sets where needed (e.g., collagen development, cross-linking, regulatory affairs, reimbursement, document/QA management, IP management, engineering development). The Company has an active Board of Directors that have started and been involved in successful healthcare startups (exits >$100m, successful IPOs) and an active Scientific/Medical Advisory Board.
This team has advanced development of BioBridge to reach commercial readiness. This included significant efforts in product development (finalizing specifications, qualifying source of materials, SOPs, packaging and extensive GLP toxicology and biocompatibility testing) that were required for 510(k), which was received in 2016. Fibralign has since completed transfer to manufacturing in support BioBridge’s commercial launch and the proposed clinical studies. These efforts included finalizing all manufacturing tooling/modules, end-to- end GMP process, documentation, securing cleanroom certification, QMS, sterilization validation and completing formal QSR and Design Reviews.
Our newest team member who just joined us in February, 2017 Dimitris Dionysiou, MD, PhD as our Chief Medical Officer. Dr. Dionysiou is a renowned microsurgeon and researcher in this field that has significant clinical experience and published studies regarding lymph node transfer procedures. He came to Fibralign from his role as Assistant Professor in Plastic Surgery (Clinical) at the Aristotle University of Thessaloniki, Greece.
What are your current status and your key company goals for the next 12 months?
Our key goals for 2017:
- Initiate the Stanford led clinical study, which will take about 18 months to complete and is expected to involve at least one additional site
- Secure CE mark for BioBridge, initiate clinical study in Europe
- ISO 13485 Certification (required for CE mark)
- Expand manufacturing capability to support initial sales
- Advance development of BioBridge for use as a combination device (cell delivery, gene therapy)
angelMD is currently circling investment interest for a potential Fibralign syndicate. If you’re interested in investing in this innovative company, please follow them on angelMD and visit this link to request more information.
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