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Bio-Tissue filling niche in ocular surface wound healing, hygiene
A new lid and eyelash cleanser joins established lines of cryopreserved amniotic membrane products used for ocular surface healing.
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A burgeoning demand for eye care is driving the development of various innovations in ophthalmology. Aside from the ubiquitous cataract and refractive technologies flooding the market, many new offerings are aimed at protecting the ocular surface and enhancing ocular hygiene.
Bio-Tissue was established as a provider of novel wound-healing products and grafts for the treatment of ocular surface diseases, such as keratitis, pterygium, corneal erosion, dry eye syndrome and chemical burns.
The company’s core offerings are based on cryopreserved human amniotic membrane, which protects fetuses in the womb. The company has developed safe and cost-effective ways to preserve and deliver these biologically active tissue products to eye care providers in a timely manner.
Amy H. Tseng, president and CEO of Bio-Tissue, said that the company is serving a growing number of physicians in the United States.
Amy H. Tseng
“In the United States, we have provided several thousand active physicians with our cryopreserved amniotic membrane products. These physicians practice at many different sized facilities, ranging from academic institutions to private clinics,” Tseng said in an email interview with Ocular Surgery News.
Bio-Tissue, a subsidiary of Tissue Tech, is a privately held company with 15 years of clinical activity and 25 years of government-funded scientific research. The company is based in the Miami area.
New product launched
Bio-Tissue is focused on expanding existing product lines and developing new therapies, Tseng said.
“We are the leading ophthalmic biologic therapeutics company, and our R&D pipeline is very full with line extensions of our current product offerings and also new therapies leveraging our core technology,” she said. “Look for innovative solutions bringing stem cell therapies in the future to our eye care providers. Additionally, our sister company, Amniox Medical, is bringing our technologies into orthopedics and wound care. There are several new products that we will launch into these markets to assist these health care providers with biologic therapeutics options.”
In January, Bio-Tissue announced the introduction of Cliradex, a preservative-free eyelid, eyelash and facial cleanser. It uses a proprietary, all-natural formulation, containing the active component found in tea tree oil, specifically designed for cleaning lashes, eyelids and the face.
The patented formulation of Cliradex, packaged as a moist towelette, is designed to cleanse the eyelashes and lids, an important ocular routine for patients with blepharitis, Demodex, ocular rosacea, dry eye, conjunctivitis and other ocular conditions, according to a Bio-Tissue news release.
“We have just launched the product at the beginning of this year, and sales already are very promising,” Tseng said. “The market for ocular hygiene products is growing rapidly and eye care practitioners are not satisfied with the current product offerings. Nothing seems to work perfectly. We believe Cliradex could be the product that can help many patients.”
Established product lines
Bio-Tissue’s main product offerings are ProKera and AmnioGraft. ProKera is a cryopreserved amniotic membrane clipped between two thermoplastic rings. It is used as a self-retaining corneal bandage to treat ocular surface diseases, such as keratitis, corneal scars, corneal burns, corneal defects, partial limbal stem cell deficiency and other ocular surface diseases. It is the only therapeutic device cleared by the U.S. Food and Drug Administration that reduces inflammation and promotes healing, according to Bio-Tissue.
AmnioGraft is used to cover the sclera after pterygium removal and is emerging as a standard of care, the company said.
“We have about 150,000 human uses of AmnioGraft and ProKera, with no adverse events. We just celebrated our 15th anniversary, and our business is expanding rapidly,” Tseng said.
Bio-Tissue products are widely available and used in more than 10,000 surgical procedures annually, Tseng said.
“Our operation has built a dependable procurement source network and quality process to ensure the safe and reliable supply of tissue for our users,” she said.
Tseng noted that when Bio-Tissue products are medically necessary, they are covered by Medicare and many private health insurance carriers. – by Matt Hasson