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Report

Teaser, summary, work performed and final results

Periodic Reporting for period 1 - CellFoam (A novel tissue remodelling biomaterial to offer a revolutionary solution for treating Urinary Incontinence in dogs)

Teaser

Summary

Urinary incontinence is the involuntary discharge of urine. Pets can be incontinent for many different reasons. Those reasons can involve the bladder, the urethra -which is the tube from the bladder to the outside-, or incontinence can be caused by abnormalities in the parts of the brain and spinal cord that control bladder function. Since the role of pets in families has evolved and is now considered an important member. Their health and welfare is gaining relevance day-to-day, and the number of pet is growing annually (78 million dogs in the United States and 81 million dogs in Europe). As such, the market to solve pet\'s health problems is also growing rapidly. In fact, there is already a pharmaceutical product in the market: Phenylpropanolamine Hydrochloride (PPA), indicated to solve Stress Urinary Incontinence (PMSI) in dogs. However, it suffers significant limitations such as inconveniences, safety and efficacy issues as well as price ($15-25/month). Problematic side effects including death (banned for humans) and many dogs eventually become non-responsive (about 20%).

We have created a new material: CellFoamâ„¢ is a novel biomaterial offering a true revolution in the field of tissue engineering due to its capacity as a scaffold and tissue adhesive.
CellFoamâ„¢ can solve in one short endoscopic procedure the unmet needs of urinary incontinence. It will provide long-term efficacy, quality of life reassurance for dogs and also for their owners.

Our objective is to accelerate the market adoption and international penetration of CellFoamâ„¢, focusing ourselves on reducing the risks (commercial, technical and financial) and preparing for the commercialization at the international level (including route-to-market, marketing strategy, growth strategy, etc.). Thus, we pursue to minimize the risks and maximize the chances of success while creating a business that is financially sustainable and can have positive cash flow in the long run.

Work performed

BioChange Ltd (formerly ProWave Medical) has invented an injectable tissue scaffold. The innovative biomaterial formulation can treat conditions of incontinence in female dogs, as well as other conditions such as periodontal disease and bone loss. The material was shown previously as safe and very well tolerated in animal tissues. In an Israeli based clinical setting, a prototype of the material was shown to be effective in treating dog incontinence for a significant amount of time. Following the action objectives (feasibility study, market analysis, risk assessment and customer acceptance), the company performed a more significant market analysis identifying key niches inside the market and focusing the market entrance to specific niche. In this context, the company has established business cooperation with leading veterinary KOLs (Key Opinion Leaders) in Europe and USA. The company has started selling its product in an Early Access Program to leading referral veterinarians USA / EU. Under the Early Access Program, the veterinarians are requested to track and report their patients with intention to future publish the product in scientific conferences and peer reviewed articles. This will increase market penetration and commercialization.
The company has finished running the clinical trial in Israel (15 dogs) and will commence a follow up for 1 year after which the company will publish the results in a peer reviewed setting.
During the clinical trials, the company identified technical weak points in the product. Those weak points were corrected by an R&D effort enabling the urologist better control of material delivery and increased working time.
Improving the product from a technical viewpoint and enhancing it with new features and functionalities will allow us to have a market ready product (2nd generation) by mid-2018, but pending additional funding.

Final results

We have developed a novel biomaterial: CellFoamâ„¢, the first product in the market that can created a de-novo tissue where it is injected, by regenerating Extra Cellular Matrix (ECM) and providing the fibroblasts a functional scaffold. It is a unique biomaterial to be used in the future to serve a multibillion $ market of tissue engineering. Our first target, is a product aimed to improve our pets and their owner\'s quality of life. This biomaterial offers a true revolution in the field of tissue engineering.