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Press Release: Nomir Medical Initiates Pivotal Trial of Its Noveon(R) Dual Wave Length Device for the Treatment of Onychomycosis
Nomir Medical Technologies, a leader in the development of optical energy technologies for medical applications, announced today the initiation of the pivotal product registration trial for the Company's advanced Noveon® direct optical energy device. The primary objective of the trial is to test the efficacy and safety of Noveon in treating patients with onychomycosis (toenail fungus). The target population for this study is patients with toenail onychomycosis, as confirmed by culture, with the goal of gaining a new FDA approval to use the device for the treatment of onychomycosis.
"This pivotal trial initiation is a major step for Nomir, moving us closer to commercial launch of our first product utilizing our proprietary dual-wavelength optical energy technology," stated Richard Burtt, CEO of Nomir Medical Technologies. "Noveon represents a novel treatment approach of using optical energy to address disease indications, such as onychomycosis, that are typically sub-optimally treated with traditional pharmaceutical drugs. In pilot studies, Noveon demonstrated 87% clinical improvements, and we are therefore hopeful for similarly positive outcomes from this investigation."
In November 2007, Nomir received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to utilize Noveon during surgical procedures of the skin, subcutaneous tissues and nasal passages in dermatology, plastic surgery, podiatry, and otolaryngology. Nomir's regulatory strategy accelerates the review process for the FDA by de-coupling the device clearance from the application clearance.
About the Noveon Pivotal Trial in Onychomycosis
Forty evaluable subjects will be enrolled in the prospective, randomized, multi-site U.S. trial. It is expected that this will provide at least 30 evaluable subjects, two-thirds of which will be treated with Noveon and the remaining serving as controls. Study objectives include assessing clinical improvement and mycological decontamination of the treated area of the nail. Patients will receive four treatments over a four-month period and will be followed up to one year following the initial treatment to assess clinical improvement and mycological response.
Nomir Medical Technologies of Waltham, Mass. is reporting that it plans to initiate a study of its Noveon® direct optical energy device. The company believes that its light-based system can target for elimination a number of bacterial and fungal infections, while also "promoting healthy tissue recovery." The first target on the company's list is everyone's favorite onychomycosis (toenail fungus). The representative for the company tells Medgadget that the device "utilizes two discrete near-infrared wavelengths at low power-- it is photobiologic in nature and doesn’t use heat. Nomir is also developing products based off of its optical energy platform for MRSA, periodontal disease, and diabetic foot ulcers (wound care) in addition to OM (onychomycosis)."
Press Release: Nomir Medical to Present Positive Onychomycosis Data for its Noveon®
Dual Wavelength Device
Waltham, MA – August 15, 2008 – Nomir Medical Technologies, a leader in the development
of optical energy technologies for anti-infective medical applications, announced today that the
Company will present an abstract detailing positive in vitro and in vivo human data from its
study of onychomycosis (toe nail fungus) using Noveon®, a novel dual wavelength optical
energy device. Noveon is designed to effect near-infrared photo-inactivation of fungi and
bacteria at energies and temperatures that are safe to normal and healthy tissue.
The detailed data will be presented in a digital session at the New Cardiovascular Horizons
“Wound Management of the Diabetic Foot and Wound Healing” conference in New Orleans,
September 10-13, 2008.
A study to treat 4 toes at a time to eliminate Onychomycosis
Device: Noveon laser
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Single Group Assignment
Primary Outcome Measures:
Complete or near complete disappearance of toenail fungus [ Time Frame: 360 days ] [ Designated as safety issue: No ]
Estimated Enrollment: 60
Study Start Date: November 2008
Estimated Study Completion Date: January 2010
Estimated Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Device: Noveon laser
Two wavelenghts of light
For professionals in the Podiatric community that are interested, here is the current information on this study:
There were 36 subjects (53 Toes) enrolled in the study.
Starting after the completion of the second of the four treatments, all subjects were required to use a non-prescriptive topical agent: 1% topical terbinafine cream applied only between the toes to control or prevent tinea interdigitalis.
Patients were instructed to not get any cream on the nails.
Use of this topical between the toes only, was in accordance with the current listed product information and is neither FDA indicated, nor FDA cleared as a treatment for onychomycosis. Other adjunctive actions that are "standard of care", such as nail debridement or nail trimming, were allowed at each investigator’s discretion.
Control subjects were handled identically in all respects to those who were treated, except for, of course, with sham “treatment” there was no energy delivery. The highest treatment site temperature was 100.5°F.
All study subjects had to have laboratory confirmation of onychomycosis by either positive culture using a selective dermatophyte test medium, or positive periodic acid-Schiff staining (PAS) from a toenail sample.
The mycology was followed and data taken for the 180 day balance of the study.
The top-line preliminary 120-day data analysis that was presented at the Council for Nail Disorders 13th Annual Scientific Meeting, and demonstrated that after Noveon treatment, 76.3 percent of the treated toes showed evidence of clinical improvement (p<0.02), and a significant drop in positive culture was seen in 74 percent of the treated toes after only two treatments (before the introduction of the tinea pedis cream.)
This data was based on at least 120 days of follow-up on all enrolled patients. Additionally, no significant adverse events were reported.
The final 180 day data, is currently under review by the FDA in an application for 510(k) approval for Onychomycosis treatment, and has been accepted for publication with a major peer-review journal.
Completed pilot study data with this device can be found at:
Bornstein, E.S., A.H. Robbins, M. Michelon (2008) Photo-inactivation of fungal pathogens that cause onychomycosis in vitro and in vivo with the noveon dual wavelength laser system. 2008 New Cardiovascular Horizons Meeting Abstracts.
In the last 4 months, I have received many worldwide inquiries from outside of the United States, concerning potential purchase of a Noveon laser for the treatment of Onychomycosis.
With this interest, my team has generated a group of prospective foreign distribution partners that will assist us in regulatory and registration efforts in the EU, Asia, South America and other areas around the globe.
Of interest to the international community, the Noveon NailLaser is a CE Marked Laser Medical Device that complies with RohS. The manufacturer of Noveon NailLaser is ISO: 13485 certified.
For these worldwide requests, we have established an international web site www.noveoninternational.com to begin categorizing and harnessing this interest by geographical area, to expedite distribution.
I would request that any worldwide party that desires more information on: (1) The Noveon NailLaser and (2) its scientific and clinical data, can now find this information at our new international web site.
Please email me through the contact page in the web site, if you are interested as (1) a customer or (2) a distributor, and we will quickly get back to you with information, as to where we are with regulatory and distribution possibilities in you part of the world.
It is with great pride that I can announce the publication of 270 day data from our pivotal onychomycosis trial with the Noveon laser in the Journal of the American Podiatric Medical Association (JAPMA).
This is the third time that this preeminent peer-reviewed podiatric journal has published study results with the Noveon laser system.
The Clinical Correspondence published this month (J Am Podiatr Med Assoc 102(2): 169-171, 2012) describes at 270 days, the outcome of the pivotal human onychomycosis trial previously published in JAPMA. That previous paper presented data at 180 days (J Am Podiatr Med Assoc 100(3): 166–177, 2010)
The data presented in JAPMA from both publications is the following:
• At Day 180, 85% of the eligible treated toenails in the pivotal study were improved by clear nail linear extent (P = .0015); 65% showed at least 3 mm and 26% showed at least 4 mm of clear nail growth. At Day 270, 35% were determined to have further improved (beyond the day 180 measurement) by direct inspection, in linear clearing or increased clear area of the nail plate, 150 days after the last treatment.
• In the initial 180 day assessment, negative culture was observed in 42% of the eligible toes after only one treatment and 75% showed negative culture after three treatments. By Day 270, 38% of all treated toes were still considered mycologically cured, 150 days after the last treatment.
• At Day 180, one treated patient showed complete nail clearance and at Day 270 three patients attained a completely normal appearance, or ‘‘clinical cure’’ 150 days after the last treatment.
With this data, the authors conclude “In addition, the data clearly show this outcome can be affected regardless of the severity of the disease. As such, it gives strong indication that the Noveon laser offers a unique, low-risk option to potentially eliminate and then control the infecting fungal agent."
To date, the only study describing an Nd:YAG used on patients for onychomycosis therapy listed in the MEDLINE database treated eight patients, and can be found here: J Cosmet Laser Ther. 2011 Feb;13(1):2-5. Epub 2011 Jan 21. In the 8 patient study, the authors concluded "The optimal number of treatment sessions for each patient needs to be determined."
To date, complete data from 3 different human onychomycosis human clinical trials performed with the Noveon, have been peer-reviewed and published four times, since 2007.
The Noveon™ Podiatric Laser is a CE approved and FDA-cleared medical device for Podiatric and Dermatologic use, supported by research and human clinical data, which is fully automatic and completely frees clinicians from manually performing procedures.
I would suggest that Podiatric and Dermatologic professionals ask ANY laser company to "show me the peer-reviewed data" before making any treatment decision for their patients.