Category Archives: Industry

SEATTLE, June 12, 2019 /PRNewswire/ — LumiThera, Inc. and Product Creation Studio today announced that LumiThera’s Valeda Light Delivery System has been honored with a silver award in the 21st Annual Medical Design Excellence Awards competition. The 2019 winners were announced at the MDEA Ceremony on Tuesday, June 11, 2019 in conjunction with the MD&M East event in New York, New York.

LumiThera, Inc. is a leader in the use of Photobiomodulation for the treatment of acute and chronic ocular diseases and disorders. Age-related macular degeneration (AMD) is the leading cause of blindness in adults over 65. Product Creation Studio worked with LumiThera from product concept through transfer to manufacturing to design and engineer a medical device that would accurately, safely, and effectively treat patients suffering from dry AMD. The resulting Valeda Light Delivery System is currently the only approved treatment using Photobiomodulation for dry age-related macular degeneration in the European Union.

The MDEA are the medtech industry’s premier design competition committed to recognizing significant achievements in medical product design and engineering that improve the quality of healthcare delivery and accessibility. The awards program celebrates the accomplishments of the medical device manufacturers, their suppliers, and the many people behind the scenes—engineers, scientists, designers, and clinicians—who are responsible for the cutting-edge products that are saving lives; improving patient healthcare; and transforming medtech—one innovation at a time.

“This award recognizes the efforts of the LumiThera and the Product Creation teams who have worked diligently to deliver a life changing treatment for those suffering from dry AMD,” said Clark Tedford, PhD, CEO and President. “We are pleased to bring the Valeda Light Delivery System to the ophthalmic market and offer dry AMD patients a treatment for this debilitating disease.”

“Product Creation Studio’s collaboration with LumiThera embodies what our organization is about: empowering innovators with the right design and development services at the right time to deliver products with impact,” Scott Thielman, Chief Technology officer of Product Creation Studio, said. “The Valeda Light Delivery System is a breakthrough product that makes a meaningful difference for patients and their families. It has been an honor to support the LumiThera team with comprehensive engineering and design services from the company’s early days through production.”

The 2019 MDEA Juror Panel selected 44 exceptional finalists in nine medical technology product categories. Products were judged based on design and engineering innovation; function and user-related innovation; patient benefits; business benefits; and overall benefit to the healthcare system. Unlike other design competitions that are merely styling contests, the MDEA jury is comprised of a balance of practicing doctors, nurses, and technicians alongside industrial designers, engineers, manufacturers, and human factors experts.

View the press release on Lumithera website at www.lumithera.com

Disclosure: I am an investor in Lumithera a) because it successfully treats an unmet medical need, (dry AMD) b) I think it will be the first billion dollar photobiomodulation company.

LumiThera Inc., a commercial stage medical device company creating a Photobiomodulation (PBM) treatment for ocular disorders and disease, today announced it is a recipient of a small business innovative research (SBIR) phase II grant from the National Institute of Health (NIH) and the division of the National Eye Institute (NEI).

The phase II grant supports a prospective, randomized, multi-center human clinical trial in U.S. subjects diagnosed with dry age-related macular degeneration (dry AMD.) The LIGHTSITE III trial, which is subject to FDA Investigational Device Exemption (IDE) approval, will test vision and examine disease pathology in the eye following PBM treatments using the Company’s Valeda™ Light Delivery System. Subjects will be followed for up to two years. In 2018, LumiThera obtained a CE mark to commercialize the Valeda™ Light Delivery System in Europe for the treatment of dry AMD. A companion post-marketing study (LIGHTSITE II) is being readied for Europe.

“Dry AMD is one of the largest unmet medical needs in medicine and its prevalence is increasing as we live longer,” commented Quan Dong Nguyen, M.D., M.Sc. and Diana V. Do, M.D., both professors of ophthalmology at the Byers Eye Institute, Stanford University School of Medicine. “In ophthalmology, currently, we have no therapies that can be offered to these patients. Both of us and many of our colleagues at Stanford, in the US, and throughout the world recognize the potential that PBM could provide as an early treatment for dry AMD, and if so, can bring significant benefits to millions of patients globally.”

“The LIGHTSITE II and III trials are part of LumiThera’s global efforts to bring forward a treatment for a debilitating eye disease that results in central loss of vision,” stated David Boyer, MD., Retina-Vitreous Associates Medical Group, Los Angeles, CA. “The planned European and US trials would create a novel treatment option for dry AMD patients, who currently have limited choices.”

“The NIH clinical grant is substantial in providing over $2.5M in funding to develop a PBM therapy for dry AMD patients in the U.S.,” stated Clark Tedford, Ph.D., President and CEO. “We are excited to have the NIH/NEI partially support the further development endeavors of LumiThera, and the grant is a significant step in the validation of the PBM technology and its potential in treating chronic eye disease.”

“We are very excited to be part of the LIGHTSITE U.S. multicenter trial.” remarked Richard Rosen, M.D., New York Eye and Ear Infirmary of Mount Sinai. “Several major U.S. centers are participating in this trial, which should help substantiate the clinical benefits of this therapy, reported to date. This trial will measure a variety of clinical and pathological outcomes and establish the long-term benefits of PBM for dry AMD patients.”

View the press release on Lumithera website at www.lumithera.com

Disclosure: I am an investor in Lumithera a) because it successfully treats an unmet medical need, (dry AMD) b) I think it will be the first billion dollar photobiomodulation company.