Sensus Healthcare Stock

Sensus Healthcare, Inc. (Sensus) operates as a medical device company.

The company provides highly effective, non-invasive, and cost-effective treatments for both oncological and non-oncological skin conditions. The company uses a proprietary low-energy X-ray technology known as superficial radiation therapy (‘SRT’), which is based on over a decade of dedicated research and development, and has successfully incorporated SRT into a portfolio of treatment devices: the SRT-100, SRT-100+, and SRT-100 Vision. As of December 31, 2022, SRT technology had been used to effectively and safely treat oncological and non-oncological skin conditions in hundreds of thousands of patients around the world.

On February 25, 2022, the company sold the assets comprising its Sculptura product.

Products and Services

SRT is the company’s core technology. As of December 31, 2022, the company had installed 686 units in 18 countries, primarily in the United States.

SRT-100

The SRT-100 is a photon x-ray low energy SRT system that provides patients an alternative to surgery for treating non-melanoma skin cancers, including basal cell and squamous cell skin cancers and other skin conditions, such as keloids. The SRT-100 is especially effective in treating primary lesions that would otherwise be difficult to treat or require extensive surgery involving sensitive areas of the head and neck regions, such as the fold in the nose, eyelids, lips, corner of the mouth, and the lining of the ear, that would otherwise lead to a less than desirable cosmetic outcome. SRT treatment procedures do not require the use of anesthetics and eliminate the need for skin grafting. The SRT-100 provides healthcare providers and patients with a safe, virtually painless, and substantially non-scarring treatment option for non-melanoma skin cancer and other skin conditions, such as keloids. It allows dermatologists to retain non-melanoma skin cancer patients, rather than referring them to specialists, while offering radiation oncologists an alternative to linear accelerator–based treatments with a process that is less invasive, more time-efficient, and improves practice economics. Revenue is primarily derived from sales of the company’s SRT-100 product line.

SRT-100 Vision

The SRT-100 Vision provides customers with additional options compared to the SRT-100 base model. These additional options allow for dedicated treatment planning and full treatment progression documentation in a patient’s record. The SRT-100 Vision provides the user with a unique SRT-tailored treatment planning application that integrates an embedded high frequency ultrasound imaging module, volumetric tumor analysis, beam margins planning, and comprehensive dosimetry parameters. This allows the user to precisely and more accurately plan and prescribe the patient-specific treatment course to maximize patient outcomes and workflow efficiency. The SRT-100 Vision also offers a comprehensive control console and workflow management that provides full record and treatment tracing, operator-level access and functional control, audio-visual patient and treated lesion monitoring, and advanced dosimetry setting and tracing.

SRT-100+

The SRT-100+ offers all the same features as the SRT-100, with the addition of an expanded energy range for customized, more precise treatment; remote diagnostics, including operation tracking; new X-ray tube with extended functionality and performance; advanced console and enhanced system mobility to optimize clinical practice; and Sentinel service program.

The company offers the Sentinel service program, which provides customers comprehensive protection for their systems. The Sentinel service program covers all parts and labor for the period of the contract and one annual preventive maintenance session that includes cooling system maintenance, high-voltage loop maintenance, filters and system cleaning, and system touch-ups, should these be required during the preventative maintenance session.

Sensus also provides, through the program, turnkey pre-and post-sale services that include the following: providing a pre-install kit for the contractors to prepare the treatment room; room retrofit and shielding; system shipping coordination and installation; system commissioning by a medical physicist (through a national physics network); system registration with the state and daily workflow documentation preparation; clinical applications training with the customer’s SRT staff; and treating the first scheduled patients with the company’s customers (onsite applications training).

Other Products

Transdermal Infusion (TDI)

TransDermal Infusion is a Class II FDA cleared biophysical alternative used to infuse high weight molecule modalities into the dermis (skin) for medical and aesthetic purposes without the use of needles. The company began distributing this product, which is manufactured in Italy, in 2022. The company distributed 23 systems during 2022.

Lasers

Sensus also distributes laser devices, for the aesthetic dermatology market, which includes applications for hair removal, vascular lesions, acne treatment, epidermal pigment removal (including removal of spots, freckles, and tattoos), skin toning, and skin rejuvenation.

Consumables

The company sells disposable lead shielding replacements, disposable radiation safety items, such as aprons and eye shields, ultrasound probe film, and disposable applicator tips, which are used to treat various sized lesions and different areas of the body. Additionally, TDI requires the purchase of disposable tips.

Sales and Marketing

The company’s focus is mainly on two primary markets, private dermatology practices and radiation oncologists in both private and hospital settings. The company employs a multi-tier sales strategy to optimize geographic coverage and focus on its key markets. This multi-tier sales model uses a direct sales force in the U.S., as well as international dealers and distributors. Sensus plans to continue selling and marketing the company’s products to both the dermatology and radiation oncology markets concurrently.

Dermatology Market

The company’s SRT products offer dermatologists a competitive advantage by allowing them to retain patients for the treatment of non-melanoma skin cancer, rather than having to refer them to other professionals. In addition to non-melanoma skin cancers, the company has had an FDA clearance to treat keloid scars since 2014. The company’s SRT has been used by over 100 U.S. dermatology practices in the treatment of keloids. Since 2017, it is also being used to treat keloids in China.

Radiation Oncology Market

For licensed radiation oncologists in the U.S., the company’s SRT products offer a simpler, faster method of treatment with a better overall patient experience. SRT offers oncologists the ability to free up more expensive radiation equipment, such as linear accelerators, for more complex procedures while providing patients with effective, non-invasive treatment options for non-melanoma skin cancer.

Other Markets

With FDA clearance to treat keloids through SRT, plastic surgeons are recognizing the opportunity to be able to provide an effective treatment solution for this benign tumor. Additionally, plastic surgeons view the non-melanoma skin cancer market as a growth opportunity that can supplement their existing services.

Manufacturing and Supply

The company uses third parties located in the U.S. to manufacture products. In 2010, the company entered into a manufacturing agreement with RbM Services, LLC (‘RbM’) pursuant to which RbM agreed to manufacture SRT-100 products.

The company maintains internal policies, procedures, and supplier management processes designed to ensure that RbM meets applicable quality standards, including FDA and International Organization for Standardization, or ISO, requirements.

Intellectual Property

The company relies on trademarks to enhance, build, and maintain the integrity of the Sensus brand.

The company possesses seven issued U.S. and Global patents. The patents relate to technology that is pertinent to the company.

The following patents were issued between August 2007 and September 2008:

U.S. Patent No. 7,372,940: Radiation therapy system with risk mitigation (expires September 30, 2025); and

U.S. Patent No. 7,263,170: Radiation therapy system featuring rotatable filter assembly (expires September 30, 2025).

The following patents were issued to the company in 2018:

Russia Patent No. 26333322: Hybrid Ultrasound-Guided Superficial Radiotherapy System and Method; and

China Patent No. ZL201380013491.7: Hybrid Ultrasound-Guided Superficial Radiotherapy System and Method.

The following patents were issued to Sensus in 2020:

U.S. Patent No. 10,596,392: Dermatology Radiotherapy System with hybrid Imager (expires July 28, 2038); and

China Patent No. ZL201710929838.2 Hybrid Ultrasound-Guided Superficial Radiotherapy System and Method (expires August 14, 2038).

One patent application was pending as of December 31, 2022.

The company also owns six U.S. trademark registrations (expiring from 2025 through 2031).

Government Regulation

The company’s medical devices are Class II devices under the FDA’s classification system.

The company is subject to unannounced establishment inspections by the FDA, as well as other regulatory agencies overseeing the implementation of and compliance with applicable state public health regulations.

In the EU/EEA, existing Sensus devices are required to comply with the essential requirements of the EU Medical Devices Directive (93/42/EEC), while any new products placed in the EU/EEA must comply with the EU Medical Device Regulation (2017/745).

Further, the advertising and promotion of Sensus’s products in the EU/EEA is subject to the laws of individual EEA Member States implementing the EU Medical Devices Directive, Directive 2006/114/EC concerning misleading and comparative advertising, and Directive 2005/29/EC on unfair commercial practices, as well as other EU/EEA Member State laws governing the advertising and promotion of medical devices.

The company has obtained approval to sell its products in Australia, Canada, China, Europe, India, Israel, Mexico, Russia, South Africa, South Korea, and Taiwan; and is seeking approval in several other countries.

The company has implemented policies and procedures related to compliance with the HIPAA privacy and security regulations, as required by law.

Research and Development

For the year ended December 31, 2022, the company incurred research and development expenses of approximately $3.5 million.

History

Sensus Healthcare, Inc., was founded in 2010. The company was incorporated under the laws of Delaware in 2010.