UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): December 10, 2020
VENUS CONCEPT INC.
(Exact name of registrant as specified in its charter)
| Delaware | 001-38238 | 06-1681204 | ||
| (State or other jurisdiction of incorporation) |
(Commission File Number) |
(IRS Employer Identification Number) |
235 Yorkland Blvd, Suite 900
Toronto, Ontario M2J 4Y8
(Address of principal executive offices, including Zip Code)
Registrant’s telephone number, including area code (877) 848-8430
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| ☐ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| ☐ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ☐ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ☐ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class |
Trading Symbol(s) |
Name of each exchange on which registered | ||
| Common Stock, $0.0001 par value per share | VERO | The Nasdaq Global Market |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☒
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
| Item 7.01. | Regulation FD Disclosure. |
On December 10, 2020, Venus Concept Inc. (the “Company”) will be using a presentation at the Venus Concept Aesthetic & Hair Restoration Technology Event which is attached hereto as Exhibit 99.1.
The Company does not intend to file any update to this presentation and makes no admission as to the materiality of any information in this Item 7.01 that is required to be disclosed solely by reason of Regulation FD.
The information in this Item 7.01, including Exhibit 99.1 attached hereto, (i) is furnished pursuant to Item 7.01 and shall not be deemed “filed” for any purpose; and (ii) shall not be deemed incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, regardless of any general incorporation language in such filing.
| Item 9.01. | Financial Statements and Exhibits. |
| Exhibit No. |
Description | |
| 99.1 | Venus Concept Aesthetic & Hair Restoration Technology Event presentation dated December 10, 2020. | |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| VENUS CONCEPT INC. | ||||||
| Date: December 10, 2020 | By: |
/s/ Domenic Della Penna | ||||
| Domenic Della Penna | ||||||
| Chief Financial Officer | ||||||
WELCOME Venus Concept Analyst meeting Domenic Serafino CEO and Director Exhibit 99.1
Growth Drivers Chad Zaring CCO
A trusted hair solution. Equipped with unique features designed for maximum profitability and high patient satisfaction. NeoGraft® delivers the next generation of follicular unit extraction and implantation. VENUS CONCEPT MULTI-YEAR GROWTH DRIVERS Venus Bliss™ Non-invasive Lipolysis System. A Safe and Effective treatment resulting in Fat reduction of the Abdomen and flanks. An intelligent hair transplant technology. Combining cutting edge robotic and AI technology. ARTAS IX™ offers precise, efficient and repeatable harvesting, site-making and implantation functionalities in a single innovative platform.
MARKET OVERVIEW NON-SURGICAL FAT REDUCTION 2. American Society of Plastic Surgeons, 2019 Plastic Surgery Statistics Report 3. The Aesthetic Society, Aesthetic Plastic Surgery National Databank Statistics, 2019 1. Non-invasive Fat Reduction Market Size, Share & Trends Analysis Report By Technology Type (Cryolipolysis, Ultrasound, Low Level Lasers), By End Use, By Region, And Segment Forecasts, 2020 - 2027. (2020, June). Base year for estimate: 2019. Retrieved December 2, 2020, from https://www.grandviewresearch.com/industry-analysis/non-invasive-fat-reduction-market. FAT REDUCTION MARKET ESTIMATED AT $992M GLOBALLY 1 ESTIMATED CAGR OF 16.4% THROUGH 2027 1 CONSISTENTLY A TOP 5 MOST IN-DEMAND NON-SURGICAL PROCEDURE 3 13% OF PATIENTS ARE MALE, ONE OF THE HIGHEST PARTICIPATION RATES BY MEN IN AESTHETICS 3 NUMBER OF TREATMENTS PERFORMED PER YEAR HAS GROWN 15% SINCE 2015 2
VENUS BLISS - CLINICAL AND ECONOMIC VALUES
v Millions of patients have been treated for a wide variety of conditions worldwide Over 70 companies are developing a robotic technology to be used in medical intervention The medical robotics market could quadruple over the next 5 years Future is already here Robotics in medicine
Medtronic Mazor Assistive Guide (22) Force surgeon compliance with plan Intuitive da Vinci Surgeon Waldo (28) Transfer, scale and stabilize surgeons' movements Human Xtensions Motorized Laparoscopy (14) Augmented hand tool ARTAS iX™ Programmable automata (6) Implement programmed plan MAJOR CLASSIFICATIONS OF MEDICAL ROBOTICS
U.S. surgical robots market, by application, 2014-2025 (USD Million) The adoption of aesthetic robotics is inevitable Robotic technologies have become standard of care for many minimally invasive procedures. The ARTAS robot has introduced robotic technology into the field of hair restoration. Venus Concept will lead the way in driving deeper penetration of robotics into aesthetic procedures.
PHYSICIAN BIO Yael Halaas, MD, FACS SPECIALTIES: Primary & reconstructive rhinoplasty Medical and surgical treatment of hair loss EDUCATION: Medical Degree, Alpha Omega Alpha Cornell University Residency – Otolaryngology/Head & Neck Surgery Albert Einstein College of Medicine in NY 1 Year Fellowship, AAFPRS Facial Plastic & Reconstructive Surgery BOARD CERTIFICATIONS: American Board of Otolaryngology American Board of Facial Plastic & Reconstructive Surgery MEDICAL SOCIETIES: American Academy of Otolaryngology – Head & Neck Surgery New York County Medical Society New York Facial Plastic Surgery Society International Society for Hair Restoration Surgery
IoT DATA & BUSINESS INSIGHTS Anat Kotler Director Product Management
DATA COLLECTION, DASHBOARDS & REPORTS Each Device reports between 25-40 measurements on each treatment Data includes information about Tx. Date & Time,Tx. Duration, patient characteristics, Tx. Mode, body area, Temp. profile, energy settings, errors & more
DATA ANALYSIS, KPIs, METRICS & BUSINESS INSIGHTS
Covid-19 Dramatic effect is reflected in utilization drop between mid March and early May, 2020 UTILIZATION VOLUME, GLOBAL INSTALL BASE Data Captured on Dec 5, 2020
DATA BUSINESS INSIGHTS- UTILIZATION VOLUME BY TERITORRY
Venus Bliss Active Install Base IoT Data Weekly Average No. Of Tx. RF Treatments Annual ROI (clinic) 3Year cumulated ROI Laser Treatments Weekly Average No. Of Tx. 4.9 8.5 $270K $810K *Based on: Laser Tx. Cost= $800 USD RF Tx. Cost = $150 USD *Estimated Average cost per Treatment, Treatment cost may vary
Venus Bliss Top 20% performing clinics IoT Data Weekly Average No. Of Tx. RF Treatments Annual ROI (clinic) 3Year cumulated ROI Laser Treatments Weekly Average No. Of Tx. 9.1 15.3 $498K $1.49M *Based on: Laser Tx. Cost= $800 USD RF Tx. Cost = $150 USD *Estimated Average cost per Treatment, Treatment cost may vary
Aesthetic & Hair Restoration Robotic Technology Eric Selvik Director Product Management
ARTAS iX r ARTAS overview ARTAS iX uses machine vision, AI, and robotics to automatically harvest and implant hair follicles in hair transplantation surgery. Replaces highly-repetitive 6-8 hr manual process with a highly-precise, highly-repeatable ~5hr automated solution. Eliminates provider fatigue and injuries inherent with long, repetitive manual procedures. Only true robotic system commercialized in aesthetic medicine.
Robotic Harvesting ARTAS iX System Stereoscopic, high speed vision system 44-micron resolution (~1/2 width of hair) 60 frames/second AI identifies all hairs in field Lengths Direction in 3-D space Number of hairs per follicular unit (F1, F2, F3, etc) AI selects best grafts and most efficient path # of hairs per FU Proper spacing per MD plan Pseudo-randomization – natural, no over-harvesting ARTAS iX User Interface Tensioner (“Grid”) with Fiducials Image-guided robotic treatment delivery Precise, repeatable, does not fatigue Safe: Stops if patient moves, waits until settled
ARTAS iX Harvesting Video ARTAS iX System Play Harvest Video Eric with Voiceover
Implantation Update ARTAS iX System ARTAS iX System is cleared to implant hair follicles in hair transplantation surgery Improved speed, repeatability and workflow in Implantation Offering as upgrade on same basic COGS, increasing profit margin Dr. Chumak gave a video presentation at the International Society of Hair Restoration Surgeons (ISHRS) Annual Meeting in October on robotic implantation.
ISHRS Robotic Implantation Presentation ARTAS iX System Play Implantation Video - Dr Chumak
PHYSICIAN BIO Q&A DR. MAXIM CHUMAK Maxim Chumak, MD, ABFM, CAQ ABHR SPECIALTIES: Family Medicine Medical and surgical treatment of hair loss EDUCATION: Medical School - American University of Antigua College of Medicine, Doctor of Medicine Michigan State University, Residency in General Surgery Wayne State University, Henry Ford Hospital, Residency in Family Medicine BOARD CERTIFICATIONS: American Board of Family Medicine MEDICAL SOCIETIES: American Board of Hair Restoration Surgeons
VEROBOTICS Eric Selvik Director Product Management Oggie Petrovic Sr. Director R&D
Directional Skin Tightening RoboCor Tighten skin through dermal micro-coring and directional compression during healing Remove up to 15% of skin in an area through excising hundreds of <1mm diameter dermal cores Apply compression during healing Results: Directional skin tightening without scarring Non-surgical skin tightening of 10-15% per treatment Initial target indications: upper arm lift, necklift, facelift, scars, stretchmarks, cellulite Anticipate ability to offer upgrade for each different indication at minimal COGS increase Consumable for each procedure
The Future is Here - System Functionality Model Treatment Planning Using AI & Machine Learning Diagnostic Assessment with Advanced Imaging Image-guided Robotic Treatment Delivery Multi-modal machine vision and imaging Other diagnostics Personalized Treatment Plans Leverage data from VC IOT Precise, repeatable, consistent Contact-less, delegatable
Current ARTAS Capabilities Other Robotic Products Detects and targets <100 micron features on skin Automatically aligns itself for ideal approach Inserts 19G needle (~1.0 mm) into dermis at +/- 100 micron depth Removes a dermal micro-core or delivers dermal hair graft at precise depth in proper 3-D orientation per Pre-op Patient Plan Detects and avoids existing hairs, scars, other important features Stops if patient moves; waits until settled ARTAS iX currently does this 1000 times per hour
Injection Robot The Robotic Future of Injectables Machine Vision: Multi-modal diagnostic imaging provides 3-D model of patient facial anatomy. Image-guidance for safe, precise treatment delivery with fewer adverse events Machine Learning and AI: Teach robot to identify and analyze dermatologic features of interest Create a personalized treatment plan based on diagnostic information and desired outcome. Provide objective proof on efficacy Robotic Automation: Precise, accurate and safe image-guided delivery of the treatment plan, with minimal variability and human error Machine Vision, AI, and Robotics can provide significant improvements in the delivery of neurotoxins and volumizers
PRODUCT & TECHNOLOGY GROWTH DRIVERS Yoni Iger, PhD VP Regulatory, Science, Technology
The Problem The Need The Solution ROBOCOR – CONCEPT SCHEMATICS Loose Skin Directional Tightening Example: Robotic Precise Lifting, Firming & Smoothening
RoboCor – Robotic tx toward directional tightening Fractional Tissue Removal and healing Coring impact Normal heal (3d à x, y, z) x z y Healing process Normal skin Directional add using tension + stabilizer (2d à x, y, z)
Post Mechanical / Ablative Coring – B&A (2 Weeks Post, Swine Model) Different Coring Methods And Directional Impact Before Tx 4.3 cm After 3.5 cm (-19%) After 3.4 cm (-17%) Before 4.1 cm x z y
Process and content First 2 years - Robocor tasks Anatomical area Experimental treatment protocol Determination of directional impact, closure means, post treatment care Dedicated tx prototype - post % V&V Parameters fine tune and human clinical We are here Add on FTR tech DDD etc. Analysis and establishment of tx protocol for preferred coring Thin skin Anatomy Thick skin Anatomy Lesion type Dimensions Lesion type Dimensions
Direction Independent Direction Dependent Natural Wound Healing In Service Of RoboCor Inflammation Hemostasis Repair Injury Healed Tissue Inflammation Contains, neutralizes or dilutes the injury causing agent or lesion Homeostasis Blood loss containment Remodeling Maturation phase of repair reduce excess ECM and alignment t Minutes To Hours Hours To Days Days To Weeks Weeks To Months Remodeling Tissue Repair Proliferative phase establishes scaffold to support and rebuild tissue
Different Closures And Phenotype Impact Overall Impact – Preclinical Brief Top Closure Dermabond Glue Tegaderm Film Immediately post coring With closure Post closure removal Coring
Perceived Protocol ROBOCOR – TREATMENT STAGES Analysis Anatomical Analysis Impact Robotic Direct FTR Impact FTR per-se (or FTR +) Directional Closure Machine visualization (X, Y, +/- Z), AI, TX algorithm Wound Healing 4 Stages Mature Directionally Regenerated Tissue Wound Closure Analysis Anatomical Analysis Machine visualization, AI, maintenance (if required) Directional impact, closing means
Histological analysis – cross tissue section Actual impact and healing post FRACTIONAL TISSUE REMOVAL and closure 0 Weeks 2 Weeks 5 Weeks
Histological Analysis – Sectioning Parallel To Skin Surface x z y Actual Impact And Healing Post FRACTIONAL TISSUE REMOVEAL And Closure A B C D
Technological, Clinical And Regulatory Milestones ROBOCOR – GO TO MARKET PLAN 2021 2022 CKO Q1 Q1 Q2 Q2 Q3 Q3 Q4 Q4 Q1 Q1 Q2 Q2 Q3 Q3 Soft Launch Clinical Prototype Tech And Prototypes Development; POC Animal Production and Limited Marketing RoboCor Product Development FDA Sub We Are Here POC US Launch Q4 Clinical - Safety Clinical - Regulatory Production and Marketing 2021 FDA Review Toward Clearance Clinical Follow Up, PMS FDA Clearance Tech/Clinical/Regulatory Plan Finalizing clinical prototype Q1 2021 Clinical safety Q1 2021 Clinical trial, MAG Q2-Q4 2021 FDA submission Q4 2021 Soft launch Q4 2021 US launch Q2 2022 2022
KOL Panel Dr. Sebastian Cotofana MD, PhD associate professor of anatomy in the Department of Clinical Anatomy at Mayo Clinic College of Medicine and Science Dr. Brian Kinney MD, FACS member of the Board of Directors of the American Society of Plastic Surgeons and a Past President of the Plastic Surgery Educational Foundation of the United States. Dr. Neil Sadick MD FAAD, FAACS, FACP, FACPh Clinical Professor of Dermatology at Weill Cornell Medical College, and President Elect of the International Society for Dermatologic Surgeons. Q&A