Ascent Medical Technology Fund I Portfolio
Bioenergy Inc. (www.bioenergy.com) is a biotechnology company focused on the development and global commercialization of high value products from the D-Ribose (a simple five-carbon sugar) family for nutritional, medical and pharmaceutical use. Ribose is found naturally in the body and is the carbohydrate backbone of RNA, DNA and ATP.
Bioenergy has a proprietary method for efficiently producing, at low cost, D-Ribose. In the sixty-five billion dollar nutritional market, Bioenergy’s products are currently being marketed to improve athletic performance, speed recovery from exercise, and reduce muscle soreness and cramping.
Bioenergy sells D-Ribose directly to companies that do their own branding and marketing, including PepsiCo and GNC. In the fifty billion-dollar medical foods market, Bioenergy has developed and is currently marketing products sold to hospitals and used in patients recovering from cardiovascular therapies including by-pass surgery, balloon angioplasty, and peripheral vascular reconstruction.
Since our investment in April 2001, Bioenergy has completed clinical studies demonstrating the effectiveness of D-Ribose in treating patients with myocardial infarct, congestive heart failure, angina and fibromyalgia. These studies suggest that D-Ribose significantly improves the clinical outcome of these patients. Finally, D-Ribose has been shown to be significantly better in the diagnosing of cardiovascular disease when compared to current methods. The company received its GRAS (Generally Regarded as Safe) approval from the US FDA in 2008.
Bioheart, Inc. (www.bioheartinc.com) is a biotechnology company focused on the discovery, development and commercialization of cellular based therapy products for the treatment of cardiovascular disease including myocardial infarction and congestive heart failure. The company believes that its patented products and procedures hold the potential to revolutionize the treatment of cardiovascular disease. Several key opinion leaders have stated that Bioheart has the potential to become a new standard of care by offering treatments that are improved, more cost effective, and lower risk than the current therapies in this one hundred and twenty billion-dollar market. At the time of our investment (7/01) the company had just completed its Phase I clinical trials demonstrating that the therapy can be delivered safely and the initial clinical outcomes suggested that the patients achieve significant improvement in their cardiac output. Since our investment the company has begun a Phase II study in the U.S. and a phase III study in Europe. There are currently over 300 patients that have been successfully treated with the Bioheart therapy. Data indicate that the therapy is highly effective.
Bioheart has also completed preclinical work on a treatment for acute myocardial infarction using stem cells derived from adipose (fat) tissue of the patient. Human work is scheduled to begin during 2009.
Finally, the company has entered the heart monitoring business, which is highly lucrative, in 2009 with an array of products that surpass any others.
Comedicus, Inc. (www.comedicus.com) manufactures and markets a cardiovascular device developed to enable the direct delivery of current existing therapeutic and diagnostic devices and drugs to the pericardial space surrounding the heart. This represents a unique opportunity in three cardiovascular markets: the two billion-dollar electrophysiology market, the ten billion-dollar drug delivery market and the four billion-dollar instrumentation market. At the time of our investment in April 2001, the company had developed a prototype and had successfully tested the prototype in animals. Since that time, the technology has been fully developed and has received regulatory approval to market in Europe. Initial sales to distributors were approximately five hundred thousand dollars. The company currently has twenty-eight patents issued or pending. The Company’s technologies are very cost-effective and will allow developing countries to treat many more patients with cardiovascular disease without increasing total health care costs. The company has been on plan and is in early acquisition discussions with three large device firms.
Enhanced Living Technologies, Inc. (www.stepmate.com) designs, develops and markets assist devices for persons whose physical capabilities have been restricted either by age or disease. When we first invested in April of 2001 the company had only one product, Step-Mate, a stairway step assembly for use as an aid in climbing a stairway. The assembly is particularly useful to elderly and physically impaired individuals who have difficulty climbing a standard stairway due to the height of the rise of the stair. The assembly provides a means of quickly, economically and safely altering the standard step arrangement found in most homes. Over the past five years, Step-Mate has taken sales from $0 to $9.5 million in 2008. The company has also developed a sales and marketing partnership with Otto Bock, a large mobility company and has added an innovative wheel chair to its product line. The company has consistently made their plan. The company is a candidate for acquisition.
First Circle Medical, Inc. is a biotechnology/device company which designs, develops, manufactures and markets patented techniques and technologies to treat patients with infectious diseases (AIDS/Hepatitis-C) and certain cancers. The company applies the science of hyperthermia and uses its technology to heat the blood of affected patients in order to increase the core body temperature to 108 degrees F. The combined indications create a fifteen billion-dollar potential market for the company. First Circle was in Phase II clinicals in the US when its funding was unable to be replenished. It is currently in hibernation awaiting a better environment for capital raising in the United States. Treatment is available in Europe.
CADx (Lifespex), Inc. We made our investment in December 2000, co-investing along with Johnson & Johnson Development. At that time, the company had developed and just completed Phase II testing of their patented platform technology designed to diagnose cancer at a very early stage, using light to fluoresce tissue. The primary focus of the company is in the twenty billion dollar a year uterine cancer diagnostic market. Current technologies (PAP and Thin Layer PAP) require the specimen to be sent out to a lab and may take up to two weeks to get results, with the results often incorrect. The Lifespex device uses light to excite tissue. Reflected light from the tissue is sent back to the device and is converted, real time, into an image that a physician can read in his office, so that the patient can be informed immediately of the diagnosis. The company felt they could achieve an accuracy of 98%. Midway through Phase III trials, the company planned an additional round of financing. The Fund bridged the company during their fund raising, securing a note to Lifespex with all the company’s assets. The company was not successful in raising the required capital and the Fund secured the assets and placed them under a shell (CADx). We are seeking an acquisition partner for the assets.
Enova (Micronet), Inc. (www.enovamedical.com) The Fund invested $1.26 million in July of 2001 at a time when the company had just completed the development of an innovative neurosurgical device to alleviate pain. The funding was used to complete the clinical testing and begin marketing the device. The company also had several other proprietary products in their pipeline. Within three years, the company successfully sold the neurosurgical device to Advanced Neuromodulation Systems Inc., which was subsequently acquired by St. Jude Medical at a nice profit for the Fund. The Fund retains an interest in Enova. The Fund expects to have further liquidity from the sale of new products that Enova is developing. The company continues to meet its development goals.
Surgical Connections, Inc. has developed an innovative and patented surgical device that is designed to connect any two contiguous sections of tissue through an endoscope. Depending on the diameter, length, and compression of the spiral connector, the device can be used to sew tissue together (heart by-pass, tissue anastomosis) or restrict or decrease the opening or diameter of an organ. The first indication for the product will be to reduce the diameter of the bladder neck opening in patients suffering from urinary stress incontinence. Stress incontinence affects approximately fifteen million women and five million men in the U.S. and has created a six billion-dollar market for the treatment of this condition. Our investment in October of 01 was used to take the concept through prototype and animal testing. The testing is now complete and we are beginning acquisition discussions with several industry leaders.
Urometrics, Inc. (www.eros-therapy.com) is a women’s healthcare company that developed and was marketing innovative, non-invasive and patient controlled medical devices to treat conditions that are not effectively treated by drugs or surgical intervention. Women’s healthcare is a multi-billion dollar growth industry, which is fueled by an aging population and increasing consumer demand for treatment options. The company’s primary focus was treating female sexual dysfunction (FSD) and urinary urge incontinence (UI). We led the company’s first preferred round and had as co-investors Johnson & Johnson Development and Tyco. The proceeds were to launch the FSD product and begin clinical evaluation of the incontinence product. We had planned to do another round of financing in mid 2004. The company was not successful in raising capital and is now in “hibernation.” We are looking for a buyer of the company’s assets.
Uromedica, Inc. (www.uromedica-inc.com) has developed and is marketing patented devices for both men and women that are self-contained, long term, post-operatively adjustable and fully implantable treatments for urinary stress incontinence (USI). USI affects over twenty million Americans and treatment modalities create a six billion-dollar market. In spite of all the advances in technology there still does not exist a simple, non-destructive, reversible and adjustable treatment.
Uromedica’s ACT and pro-ACT devices give physicians the opportunity to implant patients in an office environment so that they gain urinary control, demonstrated in over ninety percent of these patients. The company has gained approval to market the device in the international markets and is completing U.S. clinical trials. The low cost of this therapy compared to currently available therapies will result in rapid adoption in developing countries. Our investment in April of 2001 was used to complete the transfer of technology from prototype to manufacturing, launch the product in International markets and commence clinical studies in the U.S. The company has consistently met milestones and brought on Medtronic as an equity partner.
Viacell, L.L.C. (www.bioenergy.com) is a biotechnology company that is addressing one of the largest problems in the eight billion-dollar per year transfusion medicine market: the ability to store fresh platelets and red blood cells. Current technology allows for the safe storage of platelets for no more than five days and red cells for thirty. During this time interval, the viability and function of the platelets and red cells decreases geometrically. In the case of platelets, by day five, the platelets have less than five-percent viability. If platelets and red cells could be stored longer and sustain viability, then fewer units would have to be collected and fewer units would need to be given to patients. This would create a substantial cost savings for the healthcare community.
Viacell has developed a patented technology that increases shelf life of platelets to seven days and further increases viability from five percent at day five to sixty percent at day seven. The benefit of this technology is obvious and cost savings are projected to be enormous. Manufacturing and production can be conducted wherever platelets are collected.
InLet Medical, Inc (www.inletmedical.com) was sold to Cooper Surgical in 2005, for an initial downpayment with a subsequent earnout paid in 2007. This investment also provided the Fund with an exceptional return.