We have been following the MelaFind Lesion Analysis system for a number of years and were delighted to report on its CE and FDA approvals over the last 6 months. Often when a new device like this gets to market it is easy for us to forget the numerous hurdles that have been overcome just to get to a product launch. Dr. Joseph Gulfo, President and CEO of MELA Sciences, Inc, has been at the helm of MelaFind’s journey to market over the past number of years. He has taken some time to talk us about the technology behind MelaFind and the market approval process.
Gavin Corley, PhD, Medgadget: I understand that MelaFind had its origins outside of the medical device industry. Could you tell us a little bit about how the company transitioned from its early days as Electro-Optical Sciences into the medical field?
Dr. Joseph Gulfo, President & CEO of MELA Sciences, Inc. : The technology for MelaFind was originally developed under the Electro-Optical Sciences name to guide military weapons systems and help with data analysis projects for the U.S. Department of Defense (DoD). In the mid-1990s, Electro-Optical Sciences consulted with melanoma experts who asked for help in determining which clinically atypical lesions were early melanomas and which were merely benign lesions.
Electro-Optical Sciences then adapted the technology for melanoma detection and created MelaFind for dermatologic use. With the DoD, the technology was much less complicated due to the specific nature of the targets. For the dermatologic use, we had to consider the huge variance in size, shape and color of melanomas at different stages and the large variability of skin architecture.
In late 2003, I was invited by private investors to lead the company, and we started doing business as MELA Sciences in early 2010. We raised over $130 million in pre-revenue medtech funding – one of the largest public raises in history – for MelaFind.
Medgadget: I understand you have extensive experience in the medical device and biopharmaceutics industries and are no stranger to navigating the FDA approval process. We were delighted to hear that the MelaFind has received FDA approval. What sort of regulatory challenges has MelaFind faced as an innovative diagnostic tool?
Dr. Gulfo: We certainly faced a number of regulatory obstacles throughout the process of obtaining FDA approval. Before submitting the premarket approval (PMA) application for MelaFind, MELA Sciences safeguarded itself with a Binding Protocol Agreement, something rare within the FDA. In this veritable contract, the FDA stated that if the endpoints in the agreement were met, they’d expedite the approval process. After we conducted the largest study ever performed in melanoma detection and met all endpoints agreed to by the FDA in the Binding Protocol Agreement, the FDA inexplicably issued a non-approvable letter for MelaFind’s PMA application.
We challenged the FDA for the right to have an advisory panel review meeting. We were able to coordinate a remarkable “against-all-odds” positive review by a panel of outside experts. Following this, we spent six months reaching out to various people within the FDA. As more time passed, I saw countless late-stage melanoma patients die because their diseases were not caught at curable stages. According to the American Cancer Society, one American dies from melanoma every hour, and we kept that fact at the forefront of our minds throughout the approval process. The struggle was not one that my team or I took lightly. We weren’t just fighting for MELA Sciences. We were fighting for everyone who is at risk for potentially developing melanoma.
After six months with no word from the FDA, we saw no option but to file a Citizen Petition (CP) requesting that the Agency enforce the Binding Protocol Agreement that we secured years beforehand and that the agency follow its own laws and guidelines in the review of MelaFind, which they breached. This was the first time a company has ever filed a CP during an active review on a protocol agreement.
In November 2011, after a two-year struggle with the FDA, our efforts finally paid off, and we received approval of MelaFind for use in the U.S. MelaFind has also received CE mark for sale in the E.U.
Medgadget: What major technological developments have facilitated/enabled MelaFind from early prototype to its current form?
Dr. Gulfo: After adapting the technology for dermatologic use, MelaFind started out as a massive computer taking up a whole room at the NYU Pigmented Lesion Clinic. After many years in development, we were able to incorporate all of the feedback we received from leading dermatologists, and MelaFind was transformed to its current, portable size. MelaFind can fit easily into dermatology practices. The device takes just a few seconds to evaluate a lesion, and it provides final results within a minute.
MelaFind uses 10 distinct spectral bands, including near infrared bands, with 20 micron resolution to non-invasively and painlessly capture digital data from atypical pigmented skin lesions. By analyzing the data using the different bands, we are able to see different patterns in the lesions. The MelaFind lens system is composed of nine elements working together to create images of the light scattered back from the lesions that contain data on their morphology at different depths into the skin. The data is then analyzed using proprietary algorithms (data calibration, data quality control, lesion segmentation, feature extraction and lesion classification) developed using a training-and-testing database of multi-spectral data and histological diagnoses.
We conducted numerous studies of the MelaFind system, including our landmark MelaFind pivotal trial. This was the largest prospective clinical study ever conducted in melanoma detection. With the trial, we saw that for all subgroups analyzed the sensitivity of MelaFind was greater than 95 percent. Its specificity was statistically significantly higher than that of study clinicians. In other studies, we saw that MelaFind had a significantly higher rate of detection than dermatologists – 97 percent versus 72 percent.
Medgadget: The MelaFind lesion classification database is mentioned on your website as a key piece of I.P. to the MelaFind system. Could you explain its role in the system and the value it adds to the MelaFind?
Dr. Gulfo: After capturing data for irregular lesions, MelaFind analyzes the data using proprietary algorithms that were developed from our training-and-testing database. The database contains multi-spectral data and histological diagnoses for more than 10,000 biopsied lesions from over 7,000 patients. Due to the wide-ranging qualities of melanomas at different stages, a database this extensive was imperative for MelaFind to have the greatest positive impact on dermatologists’ biopsy decisions.
Medgadget: What other applications do you envision for the MelaFind imaging technology?
Dr. Gulfo: It is important to note that MelaFind is not just an “imaging technology.” MelaFind is a “smart” optical medical system in that it provides an objective evaluation of tissue from which multi-spectral data can be obtained. We are focused solely on melanoma at the moment. However, the technology is applicable to virtually any situation in which “images” can be acquired, including other skin cancers, such as basal and squamous cell carcinoma, and skin conditions that are difficult to diagnose.
Medgadget: How do you see MelaFind integrating with, or changing, current clinical practice?
Dr. Gulfo: We see MelaFind integrating quite well with current clinical practice. We are convinced that dermatologists want MelaFind. During our controlled and deliberate launch, we are working with the dermatology practices to train and assist them in using MelaFind appropriately and to incorporate its use successfully into their practices.
Since melanoma is virtually 100 percent curable when detected at its earliest stages, we developed MelaFind to be used by dermatologists who choose to obtain additional information on a pigmented skin lesion. MelaFind can offer an objective evaluation of the lesion painlessly and non-invasively.
While these results are just one element of the overall clinical assessment, they can aide dermatologists in deciding whether or not to biopsy a particular lesion. A high degree of morphological disorganization signifies a lesion that should be carefully considered for biopsy. For lesions classified by a low degree of morphological disorganization, the dermatologist should make biopsy decisions on the entire clinical context, including the patient’s family history.
We believe that MelaFind will help dermatologists continue to learn and advance their diagnostic skills. For lesions they are unsure of, MelaFind can provide additional data and show dermatologists what to look for in the future. Additionally, MelaFind evaluations are downloaded and stored in electronic health records, so dermatologists can continue to study the lesions long after the patient has left the office.
Medgadget: I believe you have recently carried end user beta testing in both North America and Germany. What were the major lessons learned from this and was there any difference between the European and North American user experience of the MelaFind system?
Dr. Gulfo: In addition to allowing us to work out some minor technical bugs and glitches, the beta studies provided excellent feedback that helped us modify the user interface, evaluation reports, terminology and messaging about what MelaFind actually does for both the dermatologist and patient audiences prior to the launch. Knowing that dermatologists have no diagnostic tool akin to MelaFind in their offices, we are purposely limiting the roll-out to just 200 systems in the U.S. and 75 systems in Europe for the first 12 months.
We feel this “commercial development” year is appropriate for a first-of-a-kind breakthrough product and will serve as the basis for more widespread dissemination of MelaFind in the future. The MelaFind commercialization effort will require innovative and creative collaboration as well as attention to detail and persistence.
Medgadget: Having got off to a great start in 2012 what does the future hold for MELA Sciences?
Dr. Gulfo: After the commercial development year, which is ongoing, we plan on more widespread distribution of MelaFind by acquiring a company in the space with an established sales and marketing channel. We prefer this route to building a large commercialization force de novo. We believe that the sales of the products in the portfolio of the target company will increase as a byproduct of the MelaFind commercialization effort. We are also presently looking at potential complementary products to acquire and bring into MELA Sciences, which has the potential of becoming a multi-billion dollar company, as others in the medtech sector have demonstrated.
Link: MELA Sciences…