FDA Designates Orphan Drug Status for TechFW Client Nanoscope Technologies

11/26/17

Nanoscope Technologies, a SmartStart client of TechFW, has received Orphan Drug Designation from the U.S. Food & Drug Administration (FDA) for its use of optogenetics, which could bring sight to those with damaged retina cells.

Orphan Drug designation was granted for its work on retinitis pigmentosa, also known as RP, which refers to a group of inherited diseases causing retinal degeneration.

“This is a very, very big deal and means their development will be fast-tracked through the FDA,” said Darlene Boudreaux, Executive Director of TechFW. “It also has some considerable financial perks.”

Sulagna Bhattacharya, the CEO/COO of Nanoscope Technologies, said Orphan Drug Designation adds seven years of marketing exclusivity, patent term extension, eligibility for special FDA grants, application fee discounts and major tax breaks on clinical development worth approximately $10 million. NanoScope Technologies, with 10 employees, was founded by Dr. Samarendra Mohanty, the President and Chief Scientific Officer.

In scientific terms, Nanoscope Technologies has developed a suite of synthetic multi-characteristic opsins having high light sensitivity for sensitizing cells toward light so that the targeted cells can be optically activated using very low intense light. In addition to its work with restoration of vision, Nanoscope is testing its light-based technologies for non-invasive cancer detection and non-invasive chronic pain management.

The virus (VMCO) and laser (NOD) techniques bypass damaged cells and inject a gene into working cells in the retina. The gene produces a protein that is light sensitive, helping the ganglion and bipolar cells regain sight. Market potential in the U.S. alone for the orphan indication (RP) is approximately 200,000 people.

Efficacy tests with rodents have been completed and no adverse effects have been noted thus far in large animal studies. Clinical trials will commence during 2018 and are expected to last 3-to-5 years.

Bhattacharya spent more than a decade in management consulting for large firms such as Deloitte and Hitachi, mostly concentrating on Business Intelligence Statistics and Risk Management. Dr. Mohanty has almost two decades of scientific, industrial and academic experience on bio-medical technologies. He is an expert in the design of bio-medical optical instrumentation, bio-photonics, neuroscience, microscopy, spectroscopy and therapy. Dr. Mohanty has worked at various laboratories in India, Germany, Italy, the U.K., and Singapore as well as the Beckman Laser Institute and Medical Clinic at the University of California – Irvine.

Nanoscope Technologies’ science combines molecular biology, bio-medical optics, neuroscience and bio-medical engineering. Its research is funded by industry as well as NIH-SBIR’s and NEI's Audacious Goal Initiative.

The company is located in Bedford because “we received approval for a pre-clinical research lab, have excellent access to TechFW, the convenience of DFW International Airport and a large number of former Alcon employees in the area,” Dr. Mohanty said.

https://www.accessdata.fda.gov/scripts/opdlisting/oopd/detailedIndex.cfm?cfgridkey=604217

TechFW is a non-profit organization that helps entrepreneurs launch and grow emerging technology companies that have a high potential for success. It mentors, coaches and relentlessly pushes them toward success. TechFW has offices at the James E. Guinn Complex in Fort Worth, at the UNT Health Science Center’s Center for BioHealth and at the University of Texas at Arlington. For more information, call Darlene Boudreaux, Executive Director, at (817) 984-9840, email her at Darlene@techfw.org or go to www.techfw.org .

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