Focal point technology: Controlling treatment depth and pattern of skin injury by a novel highly focused laser - 24/09/24

Doi : 10.1016/j.jaad.2024.09.004

Dieter Manstein, MD, PhD ^a,^b, Henry H. Chan, MD, PhD ^b,^c,^d, Jayant Bhawalkar, PhD ^e,^⁎ , Irina Erenburg, PhD ^b,^e, Hyemin Pomerantz, MD ^e,^f, Jhony Escobar, BS ^b, Zeina Tannous, MD ^d,^e,^g, Jane Yoo, MD, MPP ^e,^h, Thanh-Nga Tran, MD, PhD ^d,^e, Raj Katkam, MS ^e, R. Rox Anderson, MD ^b,^d
^a Department of Dermatology, Cutaneous Biology Research Center, Harvard Medical School, Charlestown, Massachusetts
^b Blossom Innovations, Waltham, Massachusetts
^c Division of Dermatology, Department of Medicine, The University of Hong Kong, Hong Kong SAR, China
^d Department of Dermatology, Wellman Laboratories of Photomedicine, Harvard Medical School, Boston, Massachusetts
^e AVAVA, Inc, Waltham, Massachusetts
^f VivaSkin Dermatology and Aesthetics, Wellesley, Massachusetts
^g Department of Dermatology, Lebanese American University School of Medicine, Beirut, Lebanon
^h Clinical Research Center of New York, New York, New York

^∗Correspondence to: Jayant Bhawalkar, PhD, AVAVA Inc, 275 2nd Avenue, 3rd Floor, Waltham, MA 02451.AVAVA Inc275 2nd Avenue3rd FloorWalthamMA02451

Sous presse. Épreuves corrigées par l'auteur. Disponible en ligne depuis le Tuesday 24 September 2024

Abstract

Background

Selective photothermolysis has limitations in efficacy and safety for dermal targets. We describe a novel concept using scanned focused laser microbeams for precise control of dermal depth and pattern of injury, using a 1550 nm laser that generates an array of conical thermal zones while minimizing injury to the epidermis.

Objective

To characterize the conical thermal zones in vivo and determine safe starting parameters to transition to a second phase to explore potential clinical indications.

Methods

A focused toroidal (ring) laser beam was delivered through a cold sapphire window, sparing epidermal injury in a central zone. Pulse energy, lesion depth, density, and energy delivery were titrated in ex vivo human skin and subsequently on the backs of 21 human subjects.

Results

Histology showed microscale patterns of thermal injury, which varied predictably with laser parameters. Time-course healing through histology and skin surface imaging demonstrated the ability of the device to deliver high energies without sequelae.

Limitations

Clinical data are currently being collected to further explore the safety and efficacy of the device.

Conclusion

The 1550 nm laser with focal point technology enables precise control of lesion depth while simultaneously sparing a large portion of the epidermis, lowering the risk of adverse effects.

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Key words : 1550 nm, focal point technology, fractional, laser, microbeam, nonablative, photothermolysis, treatment

Abbreviations used : CTZ, FPT, FST, MENDS, NA, PIH

Plan

Introduction

Focal point technology

Materials and methods

Ex vivo study

Human in vivo safety and dosimetry study

Results

Skin surface imaging and histology: Patterns of thermal injury and healing

Dose escalation and skin safety

Discussion

Conclusion

	Funding sources: Supported by AVAVA Inc.; Dr Anderson was supported in part as the Lancer Endowed Chair in Dermatology at Massachusetts General Hospital.
	IRB approval status: The study was reviewed and approved by Salus IRB; Protocol #: AV-19-003. Additional clinical imaging from AV-22-001, AV-22-002.