BioGend
The Future Of Orthopedic Regeneration Biologics

Advancements in medical science have created the space for cartilage regeneration treatment platform makers to dive deep into their sanctums and develop treatment packages that awe the healthcare world. One of these innovations is RevoCart, a one-step autologous cartilage repair system from BioGend. An alternative to surgical procedures like MACI and Carticel, RevoCart is a complete, easy to use platform for physicians to reduce time spent on surgery, and at cost effective rates for patients. A huge hit among patients during clinical trials, a procedure performed with BioGend’s system can be completed in under an hour compared to the usual two to four weeks.

These telltale successes have elevated the launch of BioGend Therapeutics’ RevoCart platform in the Taiwanese Market. Backed by a partner in China and funding from interested medical companies across the U.S., it imbues a natural process of cartilage repair and regeneration and plans to expand beyond its home market.

“We use an advanced autologous cartilage implantation technology to repair articular cartilage defect. We prefer to regenerate a patient’s cartilage instead of metal-based alloys while restoring joints to their original structure,” says Dr. Te-Li Chen, GM at BioGend Therapeutics.

Traditional orthopedic procedures, whether total knee or joint replacement, often require revision surgeries to replace the original with artificial joints. Although they work to an extent, patients usually experience restricted range of motion and sometime adverse side effects, including dislocation, misalignment, and nerve damage.

BioGend Therapeutics focuses on naturally repairing and restoring joints using its cutting-edge biological products. BioGend Therapeutics combines advanced material science, stem cell science, physics, developmental biology, and clinical translation to regenerate complex tissues and organ systems. Bringing a new operational technique into the joint replacement forte, RevoCart is a major step up from traditional methods. A less painful and nontime- consuming procedure, RevoCart brings all the required procedures of a cartilage repair procedure directly within hands reach of a surgeon. Physicians no longer have to schedule multiple operations for patients that span across weeks to harvest articular cartilage cells, send it to a laboratory, and wait for it to return to complete the entire surgical ordeal.

RevoCart brings a better treatment approach to cartilage repair. The first step is to remove cartilage tissues from a non-bearing site, mince and digest them, and place them in the cavity of the bioresorbable implant.

When the implant is ready, it is positioned atop the affected area and immediately begins to work. Finally, the wound is sealed, and patients can leave the hospital on the same day of undergoing the surgery. RevoCart platform’s minimally invasive nature during surgery helps reduce tissue damage and speed up recovery time.

“We ensure patients with early osteoarthritis need not replace affected joints with an artificial one,” says Dr. Chen.

For an 800-meter runner suffering from osteoarthritis and putting his career in the balance, RevoCart was a revelation that allowed him to quickly return to the track. The athlete listed to be a part of BioGend’s clinical trial, and after a series of tests, underwent surgery using the new surgical technique and equipment. The procedure took under an hour to complete, from cartilage harvesting, mincing, and enzyme digestion to implantation into the affected area. Years after receiving the product, he broke the national record twice, showcasing the brilliance and durability of the implanted cartilage regeneration product. The patients who received this technique in the pivotal trial that is initiated in 2012 still experienced a durable and satisfied outcome. A poster showing the superiority of RevoCart over microfracture at 5-year follow-up had just been published in an international orthopedic conference.

A significant gamechanger in the orthopedic biologics arena, BioGend is developing BiG-001 and BiG-006 to deliver a platform for physicians who perform bone grafting procedures. These products are designed as osteoinductive bone graft substitutes that stimulate bone growth in clinical settings. It comprises osteoinductive factor (OIF), a bone morphogenetic protein, and a tricalcium phosphate (TCP) bioceramic, enabling regenerative capabilities. Numerous surgical procedures that involve bone grafting depend on OIF and TCP, including spinal fusion, fracture fixation, and oral and maxillofacial surgery.

BiG-006 uses TCP as a carrier for OIF. It is combined with a lumbar interbody cage to achieve spinal fusion. In contrast, BiG-001 treats tibia fractures by combining OIF and beta-tricalcium phosphate granules (B-TCP). BiG-001 have completed two phase 2 trials in Japan for long bone non-union and dental bone augmentation. BioGend is looking to clear clinical trials in the U.S. and Europe for both RevoCart and BiG-001. BioGend is looking for strategic partners that will enable it to enter the lucrative American market, with more than six million people affected yearly by cartilage degradation. The medical device and platform manufacturer is gearing up to collaborate with medical companies to develop and manufacture its product in the US and EU regions. Other 510(k) products from BioGend are also in the works. In Japan, it is in discussion with a third party to complete clinical trials for BiG-001 and assume development with licensing to manufacture and launch the product.

Gathering five years of medical reporting history on the success of RevoCart, BioGend hopes to partner with companies in the orthopedic biologics market to build and release these medical marvels at various locations worldwide. Since BioGend Therapeutics products do not fall under the Taiwanese national insurance coverage, hospitals prefer them due to higher profitability. Although expensive to perform, the final billing amount is lesser than the usual thirty to forty thousand USD patients spend to undergo legacy autologous chondrocyte implantation techniques.

We use an advanced autologous cartilage implantation technology to repair articular cartilage defect. We prefer to regenerate a patient’s cartilage instead of metal-based alloys while restoring joints to their original structure

Aiming to strengthen its presence in the Taiwanese local market, BioGend Therapeutics will consistently launch products to fulfill unmet needs and remove logistical issues, including the need to outsource tissue culture procedures. It seeks to increase market penetration and build direct sales with hospitals to improve profit margins and gain sufficient funds to support its operations and R&D.

BioGend is inviting medical device manufacturers to use its first-rate production facility, designed to operate per the best medical practices and in a sterile setting. The revenue generated from the additional services will be used to further study and develop orthobiologic platforms focused on a patient’s recovery and well-being.

“We have built a fully functional GMP factory for medical device manufacture. We are seeking potential bio startups to help them accelerate their product development and time to market,” states Dr. Chen.

BioGend, to diversify its orthopedic biologics portfolio, will continue to assess bio firms with a comparable synergy, and merge or acquire target companies. Handling patients of all ages, BioGend Therapeutics aims to help individuals affected with hereditary medical conditions or sports injuries and seniors who have suffered the wear and tear of time.