Dermatology

 

Our CellFX™ System has high potential to offer improved clinical outcomes for a broad range of dermatology conditions and aesthetic skin applications for which targeted clearance of cellular lesions or structures is medically or cosmetically desirable. Current dermatology procedures to remove lesions or undesired skin tissue typically involve either excision (e.g., surgery) or the use of heat (e.g., lasers or radiofrequency energy) or cold (e.g., cryoablation). These thermal methods of tissue destruction affect both cellular and non-cellular tissue components indiscriminately, which can lead to collateral damage of the dermal foundation in the skin.

Based on our clinical data demonstrating the unique, non-thermal, cell-specific effect of Nano-Pulse Stimulation™ (NPS™) technology, we believe there is a significant opportunity for our CellFX System in aesthetic and medical dermatology in the United States. According to the 2017 Consumer Survey by the American Society for Dermatologic Surgery (ASDS), the number of consumers considering a cash-pay cosmetic procedure has more than doubled, from 30% in 2013 to 70% in 2017. The survey also highlighted that consumers ranked their dermatologist as the #1 influencer of skin procedure decisions. We have worked closely with top key opinion leaders (KOLs) in the aesthetic and medical dermatology field to identify those procedures and skin conditions in which our CellFX System and its unique NPS mechanism of action would offer a high value proposition.

Benign Lesions

The CellFX System has demonstrated positive results in the treatment of Sebaceous Hyperplasia (SH) and Seborrheic Keratosis (SK) lesions, with ongoing studies applying its potential to other difficult-to-treat lesions.

Sebaceous Hyperplasia

Seborrheic Keratosis

Warts

Acne

 

Cancerous Lesions

A clinical biomarker study using the CellFX System has also been initiated in basal cell carcinoma (BCC), the most prevalent form of skin cancer.

Basal Cell Carcinoma

 

NPS Dose Response

Our first study to establish a range of dose-response effects using the CellFX System on human skin and to demonstrate a unique cellular mechanism of action.

Earned Best of Basic Science and Translational Research Award at the 2018 American Society for Laser Medicine and Science (ASLMS) Annual Meeting.

NPS Dose Response

 


Return to the top

 

Sebaceous Hyperplasia (SH) is a common, benign, difficult-to-treat skin condition that typically presents on the face. Data from the multi-center study with leading researchers indicate that over 99% of treated SH lesions were rated as cleared or mostly cleared by clinical investigators at the 60-day post-treatment follow-up evaluation.

We believe that the successful elimination of SH lesions reflects a valuable commercial opportunity for our CellFX System in an area of unmet need and substantiates the unique ability of NPS technology to penetrate into the dermis and target deeper cellular structures without damaging the surrounding dermis.

NPS-treated SH lesion

View Press Release

 

Design

Results

Participating Researchers

 

Return to the top

 

Seborrheic Keratosis (SK) is one of the most common non-cancerous skin growths in older adults. SK usually appears as a brown, black or light tan growth on the face, chest, shoulders or back and has a waxy, scaly, slightly elevated appearance.

Multi-center study with leading researchers shows positive results for treatment of SK lesions with a single treatment of non-thermal Nano-Pulse Stimulation (NPS) technology. After a single treatment, 82% of treated SK lesions were rated as cleared or mostly cleared.

We believe that the results of this clinical study provide support to pursue commercial opportunities for the CellFX System in the treatment of SK.

NPS-treated SK lesion

View study

 

Design

Results

Participating Researchers

 

Return to the top

 

We initiated a multi-center clinical feasibility study to evaluate the safety and efficacy of our CellFX System for the treatment of non-genital cutaneous warts. Non-genital cutaneous warts are benign, grainy skin growths that are typically caused by the human papillomavirus (HPV). Results from this study will inform decisions regarding opportunities for future clinical studies for the treatment of warts.

We are currently enrolling participants for this feasibility study.

Participating Researchers

 

Return to the top

 

We initiated a multi-center clinical feasibility study to evaluate the safety and efficacy of our CellFX System for the treatment of acne on the back. Back acne is characterized by eruptions of pimples, pustules, blackheads and/or cysts, often on the upper back, and is generally caused by the same factors that trigger facial acne, namely overactive sebaceous glands that lead to the proliferation of acne-related bacteria.

We are currently enrolling participants for this feasibility study.

Participating Researcher

 

Return to the top

 

Based on a foundation of pre-clinical evidence, we believe NPS technology has the potential to play a role in immuno-oncology. This is our first human study in cancer and it will allow us to look at the ability of NPS technology to treat BCC lesion cells, as well as the immune response changes as a result of treatment. This is a multi-center study with leading researchers.

This is not a therapeutic endpoint study, but it is an important first step that enables us to move quickly to demonstrate safety and NPS effect in treating skin cancer while providing necessary information to inform decisions relative to next steps toward a follow-on study aimed at a therapeutic endpoint.

We are currently enrolling participants for this BCC biomarker study.

Participating Researchers

 

Return to the top

 

This study was given the Best of Basic Science and Translational Research Award by the ASLMS, a worldwide organization dedicated to promoting research, education and high standards of clinical care in the field of medical laser and energy-based applications.

This is the first study of NPS technology to establish a range of dose-response effect of NPS treatment in human skin and to demonstrate a unique cellular mechanism of action for all of the tested energy levels.

Between 2 and 4 hours, Caspase-3 immunohistochemistry marker confirms Regulated Cell Death (RCD)

By 24 hours, non-thermal cell death with intact cell membranes and minimal fibroplasia

View Study Poster

 

Design

Results

Conclusion

Taken together, these findings support a safe range of energy settings that have the potential to target cellular structures in the epidermis and dermis, with a low risk of damage to the non-cellular dermal tissue.

Participating Researchers

 

Return to the top