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Xalud Therapeutics is developing novel, non-opioid therapies for the treatment of neuropathic pain and osteoarthritis. Our lead product, XT-101, has shown exceptional efficacy in the leading rodent models of pain and in canine patients with neuropathic pain and osteoarthritis. XT-101 has an excellent safety profile -- it does not cause sedation, dizziness, numbness, addiction or tolerance.  7 and 28 day GLP toxicology studies have been completed with excellent results.  Xalud intends to file an IND for a Phase I/IIa trial in mid-2015 and, pending funding, initiate clinical trials thereafter.

Xalud's approach to treating pain is fundamentally different than conventional approaches. XT-101 causes the body to produce the natural anti-inflammatory IL-10.  In neuropathic pain, the use of this broad spectrum anti-inflammatory reduces inflammation around the spinal cord and reduces aberant pain signaling.  In gold-standard rodent models, a single injection of XT-101 completely eliminates neuropathic pain for 12 weeks.  We have also tested XT-101 in canine patients with severe osteoarthritis that has been resistant to standard treatments.  In these patients, XT-101 has provided long lasting pain relief resulting in dramatically increased mobility and activity levels and increased joint flexibility.

To date, Xalud's efforts have been supported by over $6 million of grant funding from the NIH, the DOD, and disease foundations.  We seek to raise $6 to $10 Million to fund our initial clinical trial or trials.  These will be placebo controlled Phase I/IIa trials in actual patients.  Because XT-101 has an extended duration, we expect that these trials will provide the safety, efficacy and biomarker data necessary to support a robust Phase II program.

Z-Cube invests strategically in technologies that benefit Zambon’s pharmaceuticals and API chemical businesses. 

Within the therapeutics sector, Z-Cube is interested in new technological platforms that enable Zambon’s therapeutic innovation (Z-Cube does not make developmental-stage investments in new chemical entities, and as Zambon only markets small molecule therapeutics, technologies related to biologics are not of interest). This includes drug delivery innovations, and other enabling technologies for therapeutics that do not have to undergo the full therapeutic approval process in order to reach the marketplace. 

Z-Cube is also interested in diagnostics, particularly point of care diagnostics, companion diagnostics and other diagnostics that are used alongside a therapeutic intervention, and diagnostics that can be used in preventative care or to lower overall healthcare costs. Zambon is also interested in diagnostic technologies used to monitor a chronic condition. 

Zambon’s therapeutic focus areas are respiratory diseases and pain (particularly chronic pain), and the firm is also interested in CNS disorders and women’s health (encompassing osteoporosis and rheumatoid arthritis in addition to ob/gyn). However in the diagnostics sector, Zambon is interested in all indications. 

Zambon is additionally interested in digital technologies that enhance communication in the healthcare space, particularly between doctor and patient or between general practitioners and specialists. This includes EMR and telehealth technologies, and devices that transmit information wirelessly. 

Zambon is also interested in innovations in high-tech chemistry, including purification of APIs, advanced crystallography, and novel custom synthesis.

The majority of medical devices get cleared for commercial deployment through the FDA’s 510(k) clearance process, which is the fastest and most economical route to market for a new medical device. ZeroTo510 has developed a unique program that enables entrepreneurs with ideas for innovative medical devices to take advantage of the fast path to market. ZeroTo510 is a first-of-its-kind cohort-based medical device accelerator. Hosted in Memphis, Tennessee, the program leverages key regional strengths in biomedical research and medical device manufacturing to create a unique program.