About Sanara MedTech

Sanara MedTech Inc. operates as a medical technology company. The company focuses on developing and commercializing transformative technologies to improve clinical outcomes and reduce healthcare expenditures in the surgical, chronic wound and skincare markets. The company markets several products across surgical and chronic wound care applications and has multiple products in its pipeline. The company licenses certain of its products from Applied Nutritionals, LLC (AN) (through a sublicense with CGI Cellerate RX, LLC (CGI Cellerate RX), an affiliate of The Catalyst Group, Inc. (Catalyst)) and Rochal Industries, LLC (Rochal); and has the right to exclusively distribute certain products manufactured by Cook Biotech Inc. (Cook Biotech). In addition, through the company’s subsidiary, Scendia Biologics, LLC (Scendia), it licenses its products from multiple manufacturers. Precision Healing Inc. (Precision Healing), a wholly owned subsidiary of the company, is developing a diagnostic imager and lateral flow assay (LFA) for assessing a patient’s wound and skin conditions. This comprehensive wound and skin assessment technology is designed to quantify biochemical markers to determine the trajectory of a wound’s condition to enable better diagnosis and treatment protocol. The company plans to submit a 510(k) premarket notification for the Precision Healing diagnostic imager in 2023. The company also plans to submit a 510(k) premarket notification for the Precision Healing LFA in 2023. In July 2022, the company entered into a membership interest purchase agreement with Scendia and Ryan Phillips (the Seller) pursuant to which it acquired 100% of the issued and outstanding membership interests in Scendia from the Seller. Since its acquisition of Scendia, the company has been selling a full line of regenerative and orthobiologic technologies, including TEXAGEN Amniotic Membrane Allograft (TEXAGEN), BiFORM Bioactive Moldable Matrix (BiFORM), AMPLIFY Verified Inductive Bone Matrix (AMPLIFY) and ALLOCYTE Advanced Cellular Bone Matrix (ALLOCYTE). In November 2022, the company established a partnership with InfuSystem Holdings, Inc. (InfuSystem) focused on delivering a complete wound care solution targeted at improving patient outcomes, lowering the cost of care, and increasing patient and provider satisfaction. The partnership is expected to enable InfuSystem to offer innovative products, including Cork Medical, LLC’s negative pressure wound therapy (NPWT) devices and supplies and its advanced wound care product line and associated services to new customers. Comprehensive Value-Based Care Strategy In June 2020, the company formed a subsidiary, United Wound and Skin Solutions, LLC (UWSS or WounDerm), to hold certain investments and operations in wound and skincare virtual consult services. Through WounDerm, the company plans to offer a comprehensive wound and skincare solution and partner with value-based care providers with the dual goal of lowering the cost to treat wounds while improving clinical outcomes. The company’s comprehensive solution consists of four key components: diagnostics, virtual consult services for wound care and dermatology, proprietary efficacious products, and a wound care and dermatology specific electronic medical record (EMR) and mobile application. The company expects these components will work synergistically to allow clinicians to analyze and treat wound and dermatology conditions more efficiently than the standard of care: Diagnostics: The company’s proprietary imager and LFA under development, which it recently acquired through its acquisition of Precision Healing, are designed to quantify key biomarkers that dictate the trajectory of wound healing and identify deficiencies to aid in treatment. Virtual Consult Services: Through its exclusive affiliation with Direct Dermatology Inc., the company can offer virtual consult services for wound care and dermatology provided by experienced, specialized physicians and clinicians. Proprietary Products: The company offers products for improving patient outcomes by addressing conditions that impact wound healing. The company is conducting multiple studies to prove the efficacy of its products while developing and exploring new products and opportunities in its six focus areas of debridement, biofilm removal, hydrolyzed collagen, advanced biologics, negative pressure wound therapy products and the oxygen delivery system segment of the wound and skincare market. EMR and Mobile Application: The company’s EMR and mobile application were developed specifically for wound care and dermatology. The company is developing the capability for the EMR and mobile application to offer wound tracking analytics, recommended treatments and decision support, and automated referrals. Product, Service and Technology Offerings and Development Programs The company is committed to developing and commercializing innovative products that address the challenges physicians face in diagnosing and treating wound and skincare ailments. The company’s surgical products, CellerateRX Surgical Activated Collagen (Powder and Gel) (collectively, CellerateRX Surgical), TEXAGEN, BiFORM, AMPLIFY and ALLOCYTE, FORTIFY TRG Tissue Repair Graft, and FORTIFY FLOWABLE Extracellular Matrix are used in a wide range of surgical specialties to help promote patient healing and reduce the risk of complications. CellerateRX Surgical products, TEXAGEN products, FORTIFY TRG Tissues Repair Graft, and FORTIFY FLOWABLE Extracellular Matrix are used in specialties, including cardiothoracic, colorectal, general surgery, hand, head and neck, high-risk obstetrics and gynecology, Mohs surgery, neurosurgery, oncology, orthopedic (hip and knee, sports, spine, joint, foot and ankle, ortho trauma and ortho oncology), plastic/reconstructive, podiatric, urology, and vascular. BiFORM, AMPLIFY, and ALLOCYTE are used in orthopedic specialties, including hip and knee, sports, spine, joint, foot and ankle, ortho trauma and ortho oncology. Substantially all of the company’s revenue is derived from the sale of surgical products. In 2021, the company launched FORTIFY TRG Tissue Repair Graft and FORTIFY FLOWABLE Extracellular Matrix, which it licenses from Cook Biotech. FORTIFY TRG Tissue Repair Graft and FORTIFY FLOWABLE Extracellular Matrix, are 510(k) cleared for use in the surgical segment. Both products are a complementary offering to CellerateRX Surgical and it is working to increase both the number of contract opportunities and facility approvals to drive further sales growth. In July 2022, through the acquisition of Scendia, the company expanded its surgical product offerings to include regenerative and orthobiologic technologies. The company choses to focus its sales and marketing on four key products: TEXAGEN, BiFORM, AMPLIFY and ALLOCYTE. As part of the integration of Scendia into Sanara, the company is continuing to work to add facility approvals for these products. The company’s chronic wound care products, HYCOL Hydrolyzed Collagen (Powder and Gel) (collectively, HYCOL), BIAKO¯S Antimicrobial Skin and Wound Cleanser (BIAKO¯S AWC) and BIAKO¯S Antimicrobial Wound Gel (BIAKO¯S AWG), are targeted for use across the post-acute continuum of care, including home health, hospice, physician offices, podiatrists, retail, skilled nursing facilities (SNFs) and wound care clinics. The company’s chronic wound care products can be used on stage I-IV pressure ulcers, diabetic foot ulcers (DFUs), venous stasis, arterial, post-surgical wounds, first- and second-degree burns and donor sites. BIAKO¯S AWC is also available in an irrigation bottle (BIAKO¯S Antimicrobial Skin and Wound Irrigation Solution) that can be used in conjunction with negative pressure wound therapy instillation and dwell, as well as other wound irrigation needs. The company has a robust pipeline of products under development for the surgical and chronic wound care markets. The company’s pipeline efforts will deepen its comprehensive portfolio of offerings, as well as allow it to address additional clinical applications. Wound care products in the company’s pipeline include next generation CellerateRX Surgical and HYCOL, a sterile antimicrobial wound solution based on the BIAKO¯S technology for use in surgical settings (BIASURGE), a CellerateRX Surgical applicator device for easier usage, an antimicrobial skin protectant and a debrider product that leverages the body’s own enzymes and moisture. The company’s WounDerm technology-based services include an EMR software platform for both wound and skin conditions, wound and skin virtual consult services (through Direct Dermatology Inc.) and diagnostic products and services for chronic wounds through Precision Healing. Following the anticipated launch of WounDerm, the company expects to be able to provide wound treatment solutions for patients across the entire acute and post-acute continuum of care. Strategy The key elements of the company’s strategy are to drive additional market penetration, as well as geographic expansion for its products; launch new innovative products; capture patients throughout the entire continuum of care; seek and establish partnerships and product, services and/or technology acquisitions; and seek and establish partnerships with Medicare Advantage, at-risk payors and other types of healthcare at-risk models. Sanara Products The company markets and distributes surgical, wound and skincare products and services to physicians, hospitals, clinics, and post-acute care settings. The company’s products are primarily sold in the U.S. surgical tissue repair and advanced wound care markets. The company is actively seeking to expand within its six focus areas of wound and skin care for the acute, post-acute, and surgical markets: debridement, biofilm removal, hydrolyzed collagen, advanced biologics, negative pressure wound therapy products, and the oxygen delivery system segment of the wound and skincare market. CellerateRX Surgical is a medical hydrolysate of Type I bovine collagen indicated for the management of surgical, traumatic, and partial- and full-thickness wounds, as well as first- and second-degree burns. It is manufactured with a proprietary process. CellerateRX Surgical Activated Collagen Powder is sterilized, packaged and designed specifically for use in the operating room or other sterile environment. CellerateRX Surgical products are primarily purchased by hospitals and ambulatory surgical centers for use by surgeons on surgical wounds. The predominance of CellerateRX Surgical products are used for a variety of surgical wounds, including those associated with orthopedic, spine, trauma and oncologic procedures. Additional surgical wounds that may benefit from the use of CellerateRX Surgical include cardiovascular, gynecologic, urologic and plastic/reconstructive related procedures. CellerateRX Surgical is used in operative cases where patients might have trouble healing normally due to underlying health complications. There is always a risk of complication with surgical wounds. This is especially true in patients with certain comorbidities, including obesity, diabetes and hypertension. These complications can include surgical wound infections, dehiscence (where an incision opens after primary closure) and necrosis. Surgeons use CellerateRX Surgical to complement the body’s normal healing process. By helping the body heal normally without complications, improved patient outcomes are achieved, thereby reducing downstream costs related to complications (such as re-operation, longer hospitalization, re-admittance, extended rehabilitative care and other additional treatments). Surgical wound complications have become increasingly problematic due to the high rates of surgical patient comorbidities and the financial strain on insurance carriers, as well as hospitals who suffer exorbitant costs for readmission of these patients within 30 days of surgery. HYCOL Hydrolyzed Collagen products are a medical hydrolysate of Type I bovine collagen intended for the management of full and partial thickness wounds, including pressure ulcers, venous and arterial leg ulcers and DFUs. HYCOL is primarily used in SNFs, wound care centers and physician offices, and is approved for reimbursement under Medicare Part B. HYCOL provides the benefit of hydrolyzed collagen directly in the wound bed. Therefore, unlike with the body’s own native collagen or native collagen products, the body does not have to break HYCOL down before use, which is extremely beneficial when treating elderly and otherwise compromised patients with comorbidities, such as diabetes and peripheral vascular disease. BIAKOS AWC is a 510(k) cleared, patented product that laboratory tests show works synergistically to effectively disrupts extracellular polymeric substances to eradicate mature biofilm microbes. BIAKOS AWC is indicated for the mechanical removal of debris, dirt, foreign materials, and microorganisms from wounds, including stage I-IV pressure ulcers, DFUs, post-surgical wounds, first- and second-degree burns, as well as grafted and donor sites. BIAKOS AWC is effective in killing planktonic microbes and immature and mature bacterial and fungal biofilms within the product. In addition, safety studies demonstrated that BIAKOS AWC is biocompatible and supports the wound healing process. BIAKOS AWC is available in an irrigation bottle (BIAKOS Antimicrobial Skin and Wound Irrigation Solution) that can be used in conjunction with NPWT instillation and dwell, as well as other wound irrigation needs. BIAKOS AWG is an antimicrobial hydrogel wound dressing that can be used alone or in combination with BIAKOS AWC. The BIAKOS AWG is also 510(k) cleared and the product launched in November 2020 to complement BIAKOS AWC. BIAKOS AWC and BIAKOS AWG are effective against planktonic microbes, as well as immature and mature biofilms within the product. When used together, the cleanser can be used initially to clean a wound and disrupt biofilms (removing 99% in 10 minutes). The gel can then be applied and remains in the wound for up to 72 hours, helping to continue disrupting biofilm microbes. In a study conducted in 2020, BIAKOS AWG, in combination with BIAKOS AWC, was compared to a number of commercially available wound cleansers to treat chronic wounds, such as pressure, diabetic and venous ulcers. The BIAKOS combination of cleansing and gel dressing demonstrated a reduction in the biofilm microbes by 7.5 logs (>99.99% reduction). FORTIFY TRG Tissue Repair Graft is a freeze-dried, multi-layer small intestinal submucosa extracellular matrix sheet. The graft is 510(k) cleared for implantation to reinforce soft tissue, is terminally sterilized, has a thin profile, is available in multiple sizes, and can be cut to size to accommodate the patient’s anatomy. FORTIFY TRG Tissue Repair Graft is provided sterile and can be hydrated with autologous blood fluid. First sales of this product occurred in the fourth quarter of 2021. FORTIFY FLOWABLE Extracellular Matrix is an advanced wound care device that presents Small Intestine Submucosa Extracellular Matrix technology in a way that can fill irregular wound shapes and depths. FORTIFY FLOWABLE Extracellular Matrix is indicated for the management of wounds, including: partial and full-thickness wounds, pressure ulcers, venous leg ulcers, diabetic foot ulcers, chronic vascular ulcers, tunneled/undermined wounds, surgical wounds (donor sites/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence sites), traumatic wounds (abrasions, lacerations, second-degree burns, and skin tears) and draining wounds. FORTIFY FLOWABLE Extracellular Matrix is provided sterile and is intended for one-time use. It is a 510(k) cleared product. First sales of this product occurred in the first quarter of 2022. TEXAGEN is a multi-layer amniotic membrane allograft used as an anatomical barrier with robust handling that can be sutured for securement if needed. BiFORM is an osteoconductive, bioactive, porous implant that allows for bony ingrowth across the graft site. It can be hydrated and used as a strip or molded into a putty to fill a bone defect. AMPLIFY is a verified inductive allograft putty with conformable handling properties. ALLOCYTE is a human allograft cellular bone matrix containing bone-derived progenitor cells and conformable bone fibers. This viable cellular allograft is ready to use upon thawing and has fibrous handling properties. Recent Published Studies on CellerateRX CellerateRX Surgical is a medical hydrolysate of Type I bovine collagen indicated for the management of surgical, traumatic, and partial- and full-thickness wounds, as well as first- and second-degree burns. CellerateRX Surgical Activated Collagen is sterilized, packaged and designed, specifically for use in the operating room (or sterile field), including additional sterility validation. It can be applied in the operating room to surgical wounds that may result from a wide variety of surgical procedures to support the wound healing environment. Several research findings involving CellerateRX Surgical powder have been noted in scientific literature. For example, in November 2021, published a retrospective study of 154 patients in JSM Neurosurgery and Spine, in which patients underwent spinal surgery and CellerateRX Surgical was utilized in the surgical wound. The study found a lower wound dehiscence rate in a high-risk patient population, when compared to previously published wound complication rates in the literature. Another retrospective case study regarding the use of CellerateRX was recently published in November 2022. This study of 54 patients undergoing spinal surgery demonstrated no incidence of surgical wound complication. Lastly, an oral presentation given at the Surgical Infection Society’s 41st Annual Meeting in April 2022 noted that, based on data from a study of 5,335 patients in a surgical registry, the use of CellerateRX Surgical in patients undergoing elective surgery resulted in a 59% overall reduction in surgical wound complications. Studies like these further support the use of CellerateRX Surgical as an effective wound management agent in spinal surgery. Sanara Technology-Based Offerings The company is developing the capability to offer various services addressing chronic wound and skin care through its subsidiary WounDerm. The company anticipates that its various service offerings will allow it to collect large amounts of data on patient conditions and outcomes that will improve treatment protocols and ultimately lead to more evidence-based treatments to improve outcomes in the future. The company’s planned service offerings through WounDerm are complemented by its existing product portfolio to complete the comprehensive wound strategy. WounDerm plans to offer the following services: EMR Software Platform for Both Wound and Skin Conditions In 2021, the company entered into an exclusive partnership with Pixalere Healthcare Inc. (Pixalere). The company’s intention is to combine Pixalere’s technology, including decision support, documentation, and wound tracking analytics, with complementary Sanara solutions that offer virtual access to expert wound and skin physicians/clinicians, advanced diagnostics, and wound care product order fulfillment. Pixalere is a cloud-based wound care software tool that empowers nurses, specialists, and administrators to deliver better care from the patient bedside. Pixalere serves and supports over 8,000 daily clinical users as they treat over 40,000 patients with wounds annually in Canada and other non-U.S. markets. Pixalere provides the following solutions to its customers: A collaboration tool for nurses and wound care specialists; wound tracking analytics; wound tracking analytics; and automated referrals. Diagnostic Products and Services for Chronic Wounds The Precision Healing product platform is a diagnostic imaging and LFA for assessing a patient’s wound and skin conditions. This comprehensive wound and skin assessment technology is designed to quantify biochemical markers to determine the trajectory of a wound’s condition to enable better diagnosis and treatment protocol. Precision Healing was formed by executives and imaging specialists at Lumicell Corporation, as well as experienced wound care scientists and physicians. The company expects to have its imaging device and LFA commercially available in 2023 and it is being integrated into the WounDerm EMR. Virtual Consultation Services for Both Wound and Skincare Conditions Direct Dermatology Inc. (DirectDerm) is a telemedicine company based in Palo Alto, California and has an exclusive network of dermatologists who have trained and/or teach at top U.S. medical institutions, and whose service is covered by many of the major health plans in the United States. WounDerm is working to integrate the DirectDerm platform into its collaboration platform to provide virtual consultations through DirectDerm’s network of board-certified dermatologists to patients in all of WounDerm’s healthcare markets. Intellectual Property In July 2021, the company acquired certain assets from Rochal, including intellectual property. With respect to the assets the company acquired from Rochal and products developed following the Rochal acquisition, its patent portfolio includes, among others, eight issued U.S. patents, including U.S. Patent No. 8,829,053 entitled ‘Biocidal Compositions and Methods of Using the Same’ (expiring December 7, 2031) relating to BIAKO¯S AWC, BIAKO¯S AWG and BIASURGE Antimicrobial Surgical Wash, as well as over 100 issued patents in foreign jurisdictions. Following the company’s acquisition by merger of Precision Healing in April 2022, its patent portfolio includes, among others, five pending U.S. patent applications, as well as one pending international patent application. In addition to the above patents, the company’s pending patent applications and new filings are representative of its ongoing efforts to broaden its portfolio as it continues developing new products for the surgical and chronic wound and skincare markets. Sales and Marketing As of December 31, 2022, the company employed 39 field sales representatives. Its field sales representatives are recruited based on their previous industry experience and professional performance. The company constantly evaluates new markets and sales opportunities to add to its sales teams as warranted. Field sales representatives are initially trained through an internal learning management system, SanaraU, which gives them further product and surgical specialty training, including wound etiology, operating room etiquette and credentialing requirements. After completing their internal training, new hire field sales representatives participate in field training with experienced field trainers to get insights into best practice, as well as real world training. The initial training period lasts approximately five weeks. Field sales representatives are supported by regular updated training modules on product information and best practices. A key component of the company’s sales and marketing efforts involves working with physicians and clinicians to champion its products in their facilities. The company works closely with surgeons and health system stakeholders to demonstrate the efficacy and beneficial impact of its surgical products and successfully navigate the hospital value analysis committee approval process, allowing its products to be sold in those facilities. Similarly, the company works with clinicians to demonstrate the efficacy of its wound care products in their respective care settings. If the company’s sales and marketing efforts are successful, the clinicians then advocate for the use of its products when medically necessary. Licensing Agreements CellerateRX Surgical Activated Collagen In August 2018, the company entered into an exclusive, world-wide sublicense agreement with CGI Cellerate RX to distribute CellerateRX Surgical and HYCOL products into the surgical and wound care markets. As amended in January 2021, the term of the sublicense extends through May 2050, with automatic successive year-to-year renewal terms. BIAKOS Antimicrobial Wound Gel and BIAKOS Antimicrobial Skin and Wound Cleanser In July 2019, the company executed a license agreement with Rochal pursuant to which it acquired an exclusive world-wide license to market, sell and further develop antimicrobial products for the prevention and treatment of microbes on the human body utilizing certain Rochal patents and pending patent applications (the BIAKOS License Agreement). The products covered by the BIAKOS License Agreement are BIAKOS AWG and BIAKOS AWC. Both products are 510(k) cleared. CuraShield Antimicrobial Barrier Film and No Sting Skin Protectant In October 2019, the company executed a license agreement with Rochal pursuant to which it acquired an exclusive world-wide license to market, sell and further develop certain antimicrobial barrier film and skin protectant products for use in the human health care market utilizing certain Rochal patents and pending patent applications (the ABF License Agreement). The products covered by the ABF License Agreement are CuraShield Antimicrobial Barrier Film and a no sting skin protectant product. Debrider License Agreement In May 2020, the company executed a product license agreement with Rochal, pursuant to which it acquired an exclusive world-wide license to market, sell and further develop a debrider for human medical use to enhance skin condition or treat or relieve skin disorders, excluding uses primarily for beauty, cosmetic, or toiletry purposes (the Debrider License Agreement). Cook Biotech Marketing and Distribution Agreement In December 2020, the company entered into a marketing and distribution agreement with Cook Biotech whereby it was appointed as the exclusive distributor in the United States of certain Cook Biotech advanced biologic products. FORTIFY TRG Tissue Repair Graft and FORTIFY FLOWABLE Extracellular Matrix are for use in the surgical care segment. Under the terms of the agreement, the company purchases the products from Cook Biotech at initial transfer prices stipulated in the agreement. The agreement will terminate in June 2024 with automatic two-year renewal terms unless notice of nonrenewal is given by one party at least one year prior to the end of the initial term or renewal term that is then in effect. Resorbable Bone Hemostat The company acquired a patent in 2009 for a resorbable bone hemostat and delivery system for orthopedic bone void fillers. This patent is not part of the company’s long-term strategic focus. Research and Development Expenses For the year ended December 31, 2022, the company’s research and development expenses were $3.4 million. Government Regulation The company’s medical products and operations are regulated by the U.S. Food and Drug Administration (FDA) and other federal and state agencies. Most of the products the company markets are regulated as medical devices in the United States under the Federal Food, Drug, and Cosmetic Act (FDCA), as implemented and enforced by the FDA. The FDA regulates the development, testing, manufacturing, labeling, packaging, storage, installation, servicing, advertising, promotion, marketing, distribution, import, export and market surveillance of its medical devices. In addition, the company markets certain products for use in surgical wound care regulated by the FDA under Section 361 of the Public Health Service Act (PHSA) (42 U.S.C. § 264) and 21 C.F.R. Part 1271. Some of the products the company markets are regulated as biologics, more specifically as human cells, tissues, and cellular and tissue-based products (HCT/Ps). HCT/Ps are regulated by the FDA’s Center for Biologics Evaluation and Research (CBER) or Center for Devices and Radiological Health (CDRH) depending on the type of product, how it is manufactured and its intended uses. HCT/Ps that meet all of the criteria described in 21 C.F.R. § 1271.10(a) are regulated by the CBER under Section 361 of the PHSA (42 U.S.C. § 264) and 21 C.F.R. Part 1271 only (361 products). Although 361 products do not require premarket review by the FDA prior to commercialization, manufacturers of 361 products must register with the FDA, submit a list of HCT/Ps manufactured, and comply with current good tissue practices (cGTP), among other things. The company’s advertising for its products and services is subject to federal truth-in-advertising laws enforced by the Federal Trade Commission (the FTC), as well as comparable state consumer protection laws. Under the Federal Trade Commission Act (FTC Act), the FTC is empowered, among other things, to prevent unfair methods of competition and unfair or deceptive acts or practices in or affecting commerce; seek monetary redress and other relief for conduct injurious to consumers; and gather and compile information and conduct investigations relating to the organization, business, practices, and management of entities engaged in commerce. The company’s business activities (and the business activities of its research and development partners and affiliates), including but not limited to, research, sales, promotion, distribution and medical education, are subject to regulation by numerous federal and state regulatory and law enforcement authorities in the United States, including the Department of Justice, the Department of Health and Human Services and its various divisions, CMS, the Health Resources and Services Administration, the Department of Veterans Affairs, the Department of Defense, and state and local governments. The company’s business activities must comply with numerous healthcare laws, including but not limited to, anti-kickback and false claims laws and regulations, as well as data privacy and security laws and regulations, such as the federal Anti-Kickback Statute and the federal civil False Claims Act. The company’s affiliated network providers and its hospital, health system and other provider clients are all regulated as covered entities under HIPAA. The company is a business associate under HIPAA when it is working on behalf of its affiliated providers. The company must also comply with HIPAA’s breach notification rule. History The company was incorporated in the state of Texas in 2001 as MB Software, Inc. In 2008, MB Software, Inc. changed its name to Wound Management Technologies, Inc. Further, the company changed its name to WNDM Medical Inc. in 2018 and to Sanara MedTech Inc. in 2019.