Rodman & Renshaw Global Investment Conference
By JEFFREY BERG, PhD
Medical Device Daily Contributing Writer
Many innovative technologies are products being researched and developed for the world's large and expanding diabetic population. Several pioneering companies in this field were featured at the annual Rodman & Renshaw (New York) Global Investment Conference.
MannKind's (Valencia, California) pursuit of Afrezza, a rapid acting breath-activated inhaled insulin, continues unabated. Insulin levels peak in only 12-13 minutes, as compared to injected insulin that is very slowly absorbed and which takes 2-3 hours to reach peak levels. It also frequently results in weight gain. Injection is the dominant method for administering insulin. Only 30% of diabetic patients use insulin pumps due to their high cost and inconvenience. Afrezza is administered from a smaller and more discrete inhaler than was used for Exubera.
MannKind has completed 61 clinical trials with over 5,600 patients. No clinically significant changes in pulmonary function were reported and no increased cardiovascular disorders. An ongoing clinical trial is intended to demonstrate superiority of Afrezza in early stage Type II diabetics that failed to benefit from using Metformin. Product approval is anticipated in 18 months, that is, 1Q14. The global market was given as 400 million diabetics. MannKind is building a facility in Danbury, Connecticut that will supply Afrezza for 400,000 patients and discussions are underway for establishing international manufacturing operations. Alfred Mann, chairman/CEO of MannKind delivered the presentation. He noted that the "FDA is getting very concerned about anti-glycemic drugs." Mann has personally invested the imponderable sum of $960 million in the company out of the total investment of $2 billion, a true measure of his commitment.
Echo Therapeutics (Philadelphia) has developed Symphony tCGM, a needle-free, wireless, continuous glucose monitoring system. The company uses its Prelude SkinPrep System to removes the stratum corneum which allows for enhanced skin permeation prior to adhering the sensor which is worn by the patient. In addition to analyte extraction, Prelude can also be used for drug delivery. The company is focusing initially on the hospital market. There is currently no system that is approved for use in U.S. hospital critical care units where continuous glucose monitoring is done routinely.
Echo has completed 10 glucose monitoring studies on a total of 131 patients which generated more than 9,000 data points. The accuracy was shown to be better than obtained using a commercial glucometer. The study yielded glucose measurements that had an average error of 12.8%, significantly better than the 16.7% error by the Dexcom (San Diego) device or 19.7% by the Medtronic (Minneapolis) device. The FDA allows for an error that does not exceed 20%. The accuracy of Echo's device was attributed to its proximity to capillaries. The company plans to complete a pivotal trial on Symphony tCGM and to begin manufacturing scale-up for validation and future product launch. The CE mark is expected to be granted in 2013. Echo anticipates that the company will ultimately secure a licensing arrangement with a strategic partner, or be acquired. The company has two strategic partnerships, with Eloquest, a subsidiary of the Ferndale Pharma Group (Ferndale, Michigan), to develop, market and sell (in North America, South America, the UK, Australia and New Zealand) the Prelude device for enhanced, fast-acting and needle-free delivery of 4% lidocaine, and with Handok Pharmaceuticals (Seoul, South Korea) to develop, market and sell the Symphony tCGM system to continuously monitor glucose levels in diabetics and hospital patients in South Korea.
Sernova (London, Ontario) is developing products which provide a natural and immune-protected environment for delivering therapeutic cells to patients. Its lead project for applying its technology is the use of its Cell Pouch system by insulin-dependent diabetics which includes 9 million Type I diabetics and about 27% of the 90 million Type II diabetics in the U.S. The company's objective is to improve upon the highly publicized Edmonton protocol which used transplants of insulin-producing Islets of Langerhans. Sernova initiated in August 2012 a 20-patient study headed by James Shapiro, MD, PhD, Director of the Clinical Islet Transplant Program at the University of Alberta (Edmonton), who was the developer of the Edmonton protocol. The Cell Pouch system uses an implantation and transplantation process that is conducted on an outpatient basis under local anesthesia. It is a scalable device that provides a natural "organ-like" environment for therapeutic cells such as insulin producing islets for diabetics. Serona is also developing Sertolin, a cell-based technology that provides an immune-privileged environment for donor cells, reducing or eliminating the need for anti-rejection drugs. Philip Toleikis, PhD, president/CEO, said that Sernova's technology "can work for any disease where there is a hormone or protein deficiency."
NeuroMetrix (Waltham, Massachusetts) was formed in 1996 as a spinoff of the Harvard Medical School (Boston) and Massachusetts Institute of Technology (Cambridge, Massachusetts). It develops medical devices that stimulate and test nerves with a primary focus on products for diabetic peripheral neuropathy (DPN), a common complication that affects more than 50% of patients with diabetes. DPN has a long undetected latent period eventually resulting in sensory loss. It is often accompanied by severe lower leg pain and foot pain. Sensory loss can lead to ulcerated wounds and amputation. The company's diagnostic device for early detection of DPN is NC-stat | DPNCheck which was launched at the end of 2011. It provides physicians with quantitative nerve conduction data at the point-of-care. It uses a disposable biosensor (cost is $15 to $20) and is a modified version of the widely used NC-stat system that the company had previously developed for general purpose nerve conduction testing.
NeuroMetrix's SENSUS pain management device is a non-invasive transcutaneous electrical nerve stimulator that is worn beneath the clothes. It is intended to be used in the symptomatic relief and management of chronic intractable pain. It is considered durable medical equipment, requires a prescription by a physician, and has broad reimbursement by commercial insurers and by Medicare. The SENSUS device was recently cleared after a 510(k) review by the FDA and the accompanying SENSUS biosensor is now under 510(k) review by the FDA. The company is expecting to launch SENSUS by the end of 2012. The company has not yet announced SENSUS pricing. Earlier in its product development pipeline, NeuroMetrix is working on products to help address the loss of sensation in the feet due to diabetic peripheral neuropathy as well as patient disease management tools.
Published September 18, 2012