Soliton, Inc. (NASDAQ: SOLY)

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Soliton files 510(k) with FDA for its Rapid Acoustic Pulse Device

510(k) Application for Premarket Clearance filed with the FDA for Rapid Acoustic Pulse (“RAP”) device in tattoo removal

 

Houston, TX  – March 21, 2019 –  Soliton, Inc., (NASDAQ: SOLY) (“Soliton” or the “Company”),a medical device company with a novel and proprietary platform technology licensed from The University of Texas on behalf of the MD Anderson Cancer Center (“MD Anderson”), today announced that it has filed for 510(k) premarket clearance with the U.S. Food and Drug Administration (“FDA”) for its first generation Rapid Acoustic Pulse (“RAP”) tattoo removal device.  The device is indicated as an accessory to the 1064 nm Q-Switched laser for black ink tattoo removal on the arms, legs and torso in Fitzpatrick Skin Type I-III individuals. Clinical trials have demonstrated that using the Company’s RAP device, in conjunction with a Q-switched laser, allows for multiple passes of laser treatment in a single treatment session, resulting in accelerated fading in comparison to stand-alone laser treatment.  The current standard of care for tattoo removal is to use a Q-switched (pulsed) laser to ablate the tattoo ink particles into pieces small enough for the body’s natural processes to remove them. Unfortunately, this current method is highly inefficient, requiring up to 10 or more office visits to achieve acceptable results. A clinical trial has demonstrated that using our Rapid Acoustic Pulse (“RAP”) device in conjunction with a Q-switched laser has the potential to produce similar results in just 2 to 3 office visits.

 

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Dr. Christopher Capelli, president and CEO of Soliton, said, “The submission of our 510(k) application for premarket clearance of our RAP device represents an important step in the commercialization of our products. We will be operating in a large industry segment that seeks the solutions our technology offers in terms of speed of tattoo removal and the potential for higher operating margins for the professional practices that adopt the RAP technology.”

 

“Our strategy is a razor/razorblade model with consumable products for single-use applications, generating recurring revenue that should allow Soliton to share in the volume growth that is expected in the coming years,” continued Dr. Capelli. “We believe this business model will serve the Company and our shareholders well as we enter into the tattoo removal segment – estimated to be approximately $4.8 billion annually by 2023 – and eventually into additional aesthetics markets. We are excited about the prospects for expanding the use of our RAP technology to address new markets and other aesthetic issues.”

 

About Soliton, Inc.

 

Soliton, Inc. is a medical device company with a novel and proprietary platform technology licensed from MD Anderson. The Company’s first planned commercial product is designed to use rapid pulses of designed acoustic shockwaves in conjunction with existing lasers to accelerate the removal of unwanted tattoos (RAP device). In addition, higher energy versions of acoustic pulse devices are in early stages of development for potential stand-alone treatment of cellulite and other indications.    Both products are investigational and are not available for sale in the United States.

 

For more information about the Company, please visit:  http://www.soliton.com

 

Forward-Looking Statements

 

Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, the ability of Soliton RAP to accelerate tattoo fading or fat removal and/or to reduce cellulite, and whether  future clinical trials related to the acceleration of existing fat removal technologies and cellulite are successful. These statements relate to future events, future expectations, plans and prospects. Although Soliton believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. Soliton has attempted to identify forward-looking statements by terminology including ”believes,” ”estimates,” ”anticipates,” ”expects,” ”plans,” ”projects,” ”intends,” ”potential,” ”may,” ”could,” ”might,” ”will,” ”should,” ”approximately” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including those discussed under in our SEC filings, including under the heading “Risk Factors” in the Form 1-A we filed with the SEC on February 13, 2019. Any forward-looking statements contained in this release speak only as of its date. Soliton undertakes no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

 

Source:  Soliton, Inc.

 

Soliton Completes Clinical Trials for Initial FDA Filing for Tattoo Indication

Houston, TX – March 19, 2019 – Soliton, Inc., (Nasdaq: SOLY) (“Soliton” or the “Company”), a medical device company with a novel and proprietary platform technology licensed from The University of Texas on behalf of the MD Anderson Cancer Center (“MD Anderson”), completed the human trials of its proprietary Rapid Acoustic Pulse (RAP) Device to support the Company’s FDA 510(k) submission.  The Company conducted three rounds of human trials to study the use of the RAP device to accelerate tattoo fading.

 

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“The human trials provided evidence of the  potential for the RAP technology to accelerate tattoo fading,” said Dr. Chris Capelli, Soliton’s President and CEO.  “The combination treatment of the RAP device and a laser outperformed a laser alone, showing an average of 80% fading after only two visits vs 44% fading for the laser alone.  After 3 Soliton Multi-Pass treatments, 100% of the treated tattoos had a ‘Complete’ (76-100% faded) response; in comparison, only 17% of the tattoos treated with the Laser Only had a ‘Complete’ response.”

 

About Soliton, Inc.

 

Soliton, Inc. is a medical device company with a novel and proprietary platform technology licensed from MD Anderson. The Company’s first planned commercial product is designed to use rapid pulses of designed acoustic shockwaves in conjunction with existing lasers to accelerate the removal of unwanted tattoos (RAP device). In addition, higher energy versions of acoustic pulse devices are in early stages of development for potential stand-alone treatment of cellulite and other indications.    Both products are investigational and are not available for sale in the United States.

 

For more information about the Company, please visit:  http://www.soliton.com

 

Forward-Looking Statements

 

Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, the ability of Soliton RAP to receive FDA clearance. These statements relate to future events, future expectations, plans and prospects. Although Soliton believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. Soliton has attempted to identify forward-looking statements by terminology including ”believes,” ”estimates,” ”anticipates,” ”expects,” ”plans,” ”projects,” ”intends,” ”potential,” ”may,” ”could,” ”might,” ”will,” ”should,” ”approximately” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including those discussed under in our SEC filings, including under the heading “Risk Factors” in the Form 1-A we filed with the SEC on February 13, 2019. Any forward-looking statements contained in this release speak only as of its date. Soliton undertakes no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

 

CONTACT:      Joe Dorame, Joe Diaz & Robert Blum

Lytham Partners, LLC

602-889-9700

soly@lythampartners.com

 

 

SOURCE:  Soliton, Inc.

Soliton Partners with Sanmina, a Global Medical Device Manufacturer

Houston, TX – March 14, 2019   – Soliton, Inc., (Nasdaq: SOLY) (“Soliton” or the “Company”), a medical device company with a novel and proprietary platform technology licensed from The University of Texas on behalf of the MD Anderson Cancer Center (“MD Anderson”), highlights the Company’s important partnership with Sanmina Corporation (Nasdaq: SANM) to advance its acoustic shockwave technology into the commercialization phase in preparation for product launch.

 

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Sanmina is a global contract electronics manufacturer and one of the world’s largest medical device manufacturers.  Under the agreement, Sanmina will provide the design and testing to advance Soliton’s RAP device for use in future clinical trials and eventually to lay the foundation for a commercial launch of the Company’s products.

 

“Working with Sanmina in this commercialization phase not only provides us with world-class quality and documentation,” commented Dr. Chris Capelli, Soliton’s CEO, “but we also believe it will make for a smoother transition to manufacturing, which we expect to begin here in the US later this year.”

 

 

About Soliton, Inc.

 

Soliton, Inc. is a medical device company with a novel and proprietary platform technology licensed from MD Anderson. The Company’s first planned commercial product is designed to use rapid pulses of designed acoustic shockwaves in conjunction with existing lasers to accelerate the removal of unwanted tattoos (RAP device). In addition, higher energy versions of acoustic pulse devices are in early stages of development for potential stand-alone treatment of cellulite and other indications.    Both products are investigational and are not available for sale in the United States.

 

For more information about the Company, please visit:  http://www.soliton.com

 

Forward-Looking Statements

 

Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, the ability of Soliton to receive clearance to market its devices and the ability of Sanmina Corporation to successfully commercialize Soliton’s technology. These statements relate to future events, future expectations, plans and prospects. Although Soliton believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. Soliton has attempted to identify forward-looking statements by terminology including ”believes,” ”estimates,” ”anticipates,” ”expects,” ”plans,” ”projects,” ”intends,” ”potential,” ”may,” ”could,” ”might,” ”will,” ”should,” ”approximately” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including those discussed under in our SEC filings, including under the heading “Risk Factors” in the Form 1-A we filed with the SEC on February 13, 2019. Any forward-looking statements contained in this release speak only as of its date. Soliton undertakes no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

 

Source:  Soliton, Inc.

Soliton’s RAP Device Received Institutional Review Board Approval of Non-Significant Risk Designation

Houston, TX – March 7, 2019 – Soliton, Inc., (NASDAQ: SOLY) (“Soliton” or the “Company”), a medical device company with a novel and proprietary platform technology licensed from The University of Texas on behalf of the MD Anderson Cancer Center (“MD Anderson”), discusses that their RAP device received institutional review board (“IRB”) approval as a non-significant risk device. Subsequent to receiving this status, the Company conducted several human clinical trials to study the use of the RAP device to accelerate tattoo fading and initiated a proof-of-concept trial in humans for the reduction of cellulite.

 

Soliton’s RAP device accelerates tattoo removal in part by providing dermal clearing of laser-generated vacuoles during laser treatment. This designation by the IRB allows the Company to use its device in human clinical trials.

 

The Institutional Review Board (IRB) is an FDA registered constituted group that has been formally designated to review and monitor biomedical research involving human subjects. In accordance with FDA regulations, an IRB has the authority to approve, require modifications (to secure approval), or disapprove research. This group review serves an important role in the protection of the rights and welfare of human research subjects.

 

“The NSR designation makes it very straight forward for us to conduct clinical trials with our technology,” commented Dr. Chris Capelli, Soliton’s President and CEO. “This applies not only to the clinical data we are presenting to the FDA with regard to accelerating tattoo removal, but potential future indications like cellulite reduction. We believe this allows us to move more quickly in developing Soliton RAP.”

 

About Soliton, Inc.

Soliton, Inc. is a medical device company with a novel and proprietary platform technology licensed from MD Anderson. The Company’s first planned commercial product will use rapid pulses of designed acoustic shockwaves to dramatically accelerate the removal of unwanted tattoos. The Company is based in Houston, Texas, and is actively engaged in bringing its Rapid Acoustic Pulse (“RAP”) device to the market. The Company believes this “Soliton” method can not only dramatically accelerate tattoo removal, but also has the potential to lower removal cost for patients, while increasing profitability to practitioners. Soliton has discovered other capabilities of the RAP technology during preclinical testing, including the potential to assist existing fat reduction technology in the reduction of fat as well as reducing the appearance of cellulite by creating mechanical stress at the cellular level and inducing significant collagen growth.

 

For more information about the Company, please visit: http://www.soliton.com

 

Forward-Looking Statements

Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, the ability of Soliton RAP to receive FDA clearance, as well as reduce the appearance of cellulite in humans. These statements relate to future events, future expectations, plans and prospects. Although Soliton believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. Soliton has attempted to identify forward-looking statements by terminology including ”believes,” ”estimates,” ”anticipates,” ”expects,” ”plans,” ”projects,” ”intends,” ”potential,” ”may,” ”could,” ”might,” ”will,” ”should,” ”approximately” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including those discussed under in our SEC filings, including under the heading “Risk Factors” in the Form 1-A we filed with the SEC on February 13, 2019. Any forward-looking statements contained in this release speak only as of its date. Soliton undertakes no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

 

Source:  Soliton, Inc.

Soliton Receives FDA Approval for Small Business Designation

The Company qualifies for reduced or waived fees for medical device submissions with the FDA

 

Houston, TX – March 4, 2019  – Soliton, Inc., (NASDAQ: SOLY) (“Soliton” or the “Company”), a medical device company with a novel and proprietary platform technology licensed from The University of Texas M.D. on behalf of the MD Anderson Cancer Center (“MD Anderson”), today announced that it has received notice from the U.S. Food and Drug Administration (“FDA”) that the Company has qualified for the “Small Business” designation under the Medical Device User Fee Amendments (“MDUFA”). As a Small Business under the MDUFA, Soliton qualifies for a reduce or waived fee for medical device submissions made during the fiscal year 2019.

 

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Dr. Christopher Capelli, president and CEO of Soliton, said, “We are pleased to have qualified for Small Business status allowing us to receive reduced or waived fees for our FDA submissions. We appreciate the opportunity to submit device applications for review and approval at more favorable rates. In certain submissions, the savings could be dramatic. This helps us to operate more efficiently. Our plan is to is to submit our Rapid Acoustic Pulse (“RAP”) device for tattoo removal for premarket clearance with the FDA under our new status in the near future.”

 

The MDUFA rates cover a number of submissions that are routinely made to the FDA for review and approval. The rate table assigns fees for the fiscal year – which ends on September 30, 2019 – for the application type submitted for review along with the Standard Fee and the Small Business fee for companies that qualify for the designation.

 

The table of 2019 MDUFA rates can be accessed at:

https://www.fda.gov/ForIndustry/UserFees/MedicalDeviceUserFee/ucm615142.htm

 

 

About Soliton, Inc.

 

Soliton, Inc. is a medical device company with a novel and proprietary platform technology licensed from MD Anderson. The Company’s first planned commercial product will use rapid pulses of designed acoustic shockwaves to dramatically accelerate the removal of unwanted tattoos. The Company is based in Houston, Texas, and is actively engaged in bringing this device to the market. The Company believes this “Soliton” method can not only dramatically accelerate tattoo removal, but also has the potential to lower removal cost for patients, while increasing profitability to practitioners, and to reduce the potential for unwanted side effects from current laser removal methods.  Soliton has discovered other capabilities of the RAP technology during preclinical testing, including the potential to assist existing fat reduction technology in the reduction of fat as well as reducing the appearance of cellulite by creating mechanical stress at the cellular level and inducing significant collagen growth.

 

For more information about the Company, please visit:  http://www.soliton.com

 

Forward-Looking Statements

 

Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, the ability of Soliton RAP to accelerate tattoo fading or fat removal and/or to reduce cellulite, and whether  future clinical trials related to the acceleration of existing fat removal technologies and cellulite are successful. These statements relate to future events, future expectations, plans and prospects. Although Soliton believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. Soliton has attempted to identify forward-looking statements by terminology including ”believes,” ”estimates,” ”anticipates,” ”expects,” ”plans,” ”projects,” ”intends,” ”potential,” ”may,” ”could,” ”might,” ”will,” ”should,” ”approximately” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including those discussed under in our SEC filings, including under the heading “Risk Factors” in the Form 1-A we filed with the SEC on February 13, 2019. Any forward-looking statements contained in this release speak only as of its date. Soliton undertakes no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

 

Source:  Soliton, Inc.

Soliton Receives Additional Patent for Breakthrough Acoustic Shockwave Technology

Rapid Acoustic Pulse device granted patent in China; bringing a total of 38 issued or pending patents

 

Houston, TX – February 26, 2019 – Soliton, Inc., (Nasdaq: SOLY), (“Soliton” or the “Company”), a medical technology company that has developed a new acoustic shockwave device, today announced that the National Intellectual Property Administration (Chinese Patent Office) has issued a notice of grant for Chinese Patent Application No. 201280041817.2, based on International Application No.PCT/IS2012/046674; Entitled “Apparatus for Generating Therapeutic Shockwaves And Applications of Same,” by Christopher C. Capelli.

 

Dr. Chris Capelli, CEO of Soliton, said,  “The granting of this patent is an important milestone for Soliton. With the issuance of this patent in the People’s Republic of China (“PRC”) for our leading-edge Rapid Acoustic Pulse (“RAP”) technology and with our pending United States patents, we are well positioned to develop two of the major consumer markets in the world. We have a strong portfolio that now numbers 38 issued and pending patents that we believe provides Soliton a meaningful competitive advantage in removing unwanted tattoos in about one-third of the time of traditional procedures, with less pain and discomfort, and at a lower overall cost.”

 

Soliton has discovered other capabilities of the RAP technology during preclinical testing, including the potential to assist existing fat reduction technology in the reduction of fat as well as potentially reducing the appearance of cellulite by creating mechanical stress at the cellular level and inducing significant collagen growth.  Importantly, this potential indication could position Soliton RAP as a stand-alone device, without the need for lasers or other procedures.

 

Dr. Capelli concluded, “If our ongoing clinical trials prove to be effective in cellulite and fat removal, we will dramatically expand our addressable markets. We are excited with the opportunities ahead in the coming years.”

 

 

About Soliton, Inc.

 

Soliton, Inc. is a medical device company with a novel and proprietary platform technology licensed from MD Anderson. The Company’s first planned commercial product will use rapid pulses of designed acoustic shockwaves to dramatically accelerate the removal of unwanted tattoos. The Company is based in Houston, Texas, and is actively engaged in bringing this device to the market. The Company expects to file for premarket clearance with the U.S. Food and Drug Administration (“FDA”) for its’ first device in the first quarter of 2019 and expects to receive clearance to market the device in mid 2019. This initial filing is limited to the Company’s device used in conjunction with the 1064 nm Q-switched laser to enable effective multiple pass laser treatments in a single office session to accelerate removal of black tattoos on the arms, legs and torso in Fitzpatrick Skin Type I-III individuals. While the Company believes its’ technology has many potential applications, the Company has initially focused on the removal of tattoos, where both animal and human studies have shown promising results. The current standard of care for tattoo removal is to use a Q-switched (pulsed) laser to ablate the tattoo ink particles into pieces small enough for the body’s natural processes to remove them. Unfortunately, this current method is highly inefficient, requiring up to 10 or more office visits to achieve acceptable results. A clinical trial has demonstrated that using the Company’s RAP device, in conjunction with a Q-switched laser, has the potential to produce similar results in just 2 to 3 office visits versus the industry average of 10 or more with a stand-alone laser. The Company believes this “Soliton” method can not only dramatically accelerate tattoo removal, but also has the potential to lower removal cost for patients, while increasing profitability to practitioners, and to reduce the potential for unwanted side effects from current laser removal methods.

 

 

For more information about the Company, please visit:  http://www.soliton.com

 

Forward-Looking Statements

 

Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, the ability of Soliton RAP to accelerate tattoo fading or fat removal and/or to reduce cellulite, and whether  future clinical trials related to the acceleration of existing fat removal technologies and cellulite are successful. These statements relate to future events, future expectations, plans and prospects. Although Soliton believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. Soliton has attempted to identify forward-looking statements by terminology including ”believes,” ”estimates,” ”anticipates,” ”expects,” ”plans,” ”projects,” ”intends,” ”potential,” ”may,” ”could,” ”might,” ”will,” ”should,” ”approximately” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including those discussed under in our SEC filings, including under the heading “Risk Factors” in the Form 1-A we filed with the SEC on February 13, 2019. Any forward-looking statements contained in this release speak only as of its date. Soliton undertakes no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

 

CONTACT:

Joe Dorame, Joe Diaz & Robert Blum

Lytham Partners, LLC

602-889-9700

soly@lythampartners.com

 

Source:  Soliton, Inc.

Soliton, Inc. Completes IPO and Begins Trading on Nasdaq Under Ticker Symbol “SOLY”

NEW YORK, HOUSTON and LOS ANGELES, Feb. 19, 2019 – Soliton, Inc. (NASDAQ: SOLY) (“Soliton” or the “Company”), a pre-revenue stage medical device company with a novel and proprietary platform technology licensed from The University of Texas on behalf of the MD Anderson Cancer Center (“MD Anderson”), today announced that its shares have commenced trading on the Nasdaq Capital Market under the symbol “SOLY”.  Soliton closed its Regulation A+ Tier 2 offering (the “Offering”) by selling 2,172,591shares of its common stock at the IPO price of $5.00 each, resulting in aggregate gross proceeds of $10,862,955, before deducting underwriting commissions and other related expenses.  Boustead Securities, LLC (“Boustead”) was the sole underwriter of the Soliton initial public offering (“IPO”), the California-based investment bank’s second Nasdaq IPO of 2019.

 

“We are thrilled to begin trading on Nasdaq,” said Soliton CEO Chris Capelli.  “The closing of Soliton’s IPO marks the beginning of a new chapter for our company and its dedicated investors, both long-term and those that have come on board in this Nasdaq IPO. We will continue to push forward with our proprietary technology for tattoo removal and for cellulite reduction by completing further clinical and preclinical trials before bringing the Soliton’s Rapid Acoustic Pulse (“RAP”) shockwave device to a large addressable market,” Capelli stated.

 

“Congratulations to Soliton CEO Chris Capelli and the entire Soliton team for a promising trading debut on Nasdaq,” said Boustead’s Head of Equity Capital Markets, Dan McClory.  “The successful completion of the first Reg A+ IPO on Nasdaq or the NYSE in over one year by any company is a particularly important milestone, and it says a lot about the resilience and commitment of Soliton, its investors, advisors, and underwriter,” McClory concluded.

 

The Company intends to use the net proceeds of the IPO offering primarily to develop and commercialize the RAP device; conduct further clinical trials for new indications; pay license fees and fund research and development; and for general working capital.

 

Soliton’s patented RAP device uses acoustic shockwaves that, in clinical trials, accelerated the speed of tattoo removal when used in conjunction with lasers, delivering results in as little as 2 to 3 treatments versus the 10 to 12 average with the current standard of care lasers alone. In addition to tattoo removal, Soliton discovered other capabilities of its technology during preclinical testing. Among them, the Company observed that their RAP device may have the potential to improve skin laxity as well as the appearance of cellulite by creating mechanical stress at the cellular level and inducing collagen growth. These clinical and preclinical trials are in early stages and intended as a proof-of-concept and there are no assurances that the trials will have a successful outcome.

 

An offering circular on Form 1-A relating to this U.S. offering was filed with the Securities and Exchange Commission (“SEC”) and was qualified by the SEC as of November 27, 2018. The offering of these securities was made only by means of an offering circular on Form 1-A. The final offering circular is available at https://www.flashfunders.com/solitonhttps://www.sec.gov or may be obtained from Boustead Securities at +1 (949) 502-4409 or offerings@bousted1828.com

 

About the Company

Soliton, Inc. is a pre-revenue stage medical device company with a novel and proprietary platform technology licensed from MD Anderson. The Company’s first commercial product uses rapid pulses of designed acoustic shockwaves to dramatically accelerate the removal of unwanted tattoos. The Company is based in Houston, Texas, and is actively engaged in bringing this device to the market. The Company expects to file for premarket clearance with the U.S. Food and Drug Administration (“FDA”) for its first device in the first quarter of 2019 and expects to receive clearance to market the device in mid-2019. For more information about the Company, please visit: http://www.soliton.com.

 

About Boustead Securities, LLC

Boustead Securities, LLC (“Boustead”) is an investment banking firm that executes and advises on IPOs, mergers and acquisitions, capital raises and restructuring assignments in a wide array of industries, geographies and transactions, for a broad client base. Boustead’s core value proposition is the ability to create opportunity through innovative solutions and tenacious execution. With experienced professionals in the United States and around the world, Boustead’s team moves quickly and provides a broad spectrum of sophisticated financial advice and services. For more information about Boustead, please visit www.boustead1828.com

 

CONTACT:

Boustead Securities, LLC:

Dan McClory, Head of Equity Capital Markets

+1 (949) 502 4408

dan@boustead1828.com

 

About FinTech Global Markets, Inc.

FinTech Global Markets, Inc. (“FTGM”) was founded in 2012 and is headquartered in Southern California. FTGM owns and operates a FINRA member broker-dealer, FinTech Clearing, LLC; FlashFunders Shareholder Services, LLC, a SEC-registered transfer agent; FlashFunders Funding Portal, LLC, a FINRA member funding portal; and two investment advisors, Maco.la Management, Inc. and Initiate Advisors, LLC. Through these subsidiaries, FTGM operates a U.S.-based online securities platform whose underlying technology and regulatory infrastructure are designed to enable issuers to engage in Regulation D, Regulation A (known as Reg A+), Regulation S, Regulation CF and fully registered S-1 and F-1 Initial Public Offerings on NASDAQ in compliance with applicable federal, state and non-U.S. securities laws.  www.flashfunders.com

 

This press release is neither an offer to sell nor a solicitation of an offer to buy any securities of the Company, including without limitation the common stock nor shall such securities be offered or sold in the United States absent registration or an applicable exemption from registration, nor shall there be any offer, solicitation or sale of any of the Company’s securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such state or jurisdiction.

 

Regulation A+ Offerings

An Offering Circular regarding Soliton, Inc. (“Soliton”) has been filed with the Securities and Exchange Commission (“SEC”). The SEC has qualified the Soliton Offering Circular, which only means that we may make sales of the securities described in its Offering Circular. It does not mean that the SEC has approved, passed upon the merits, or passed upon the accuracy or completeness of the information in Soliton’s Offering Circular. You may obtain copies of the Offering Circular for Soliton here: https://www.sec.gov/Archives/edgar/data/1548187/000162827918000315/soliton253g2.htm

 

Liquidity Risk-Regulation A+ Offerings

An investment in Soliton has a high degree of risk, including, but not limited to, a small equity market capitalization and lack of significant public float, which may impair the liquidity of these investments. Soliton can make no assurances about the success of its products, licensing or marketing efforts; consequently, investors in Soliton may lose some or all of their investments.

 

Safe Harbor Statement

The Company has made statements in this press release that are considered “forward-looking statements” which are usually identified by the use of words such as “anticipates,” “believes,” “estimates,” “expects,” “intends,” “may,” “plans,” “projects,” “seeks,” “should,” “will,” and variations of such words or similar expressions. All statements other than statements of historical fact in this press release are forward-looking statements. These forward-looking statements reflect our current views about our plans, intentions, expectations, strategies and prospects, which are based on the information currently available to us and on assumptions we have made. Although we believe that our plans, intentions, expectations, strategies and prospects as reflected in or suggested by those forward-looking statements are reasonable, we can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved. Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a variety of risks and factors that are beyond our control. For further discussion of the factors that could affect outcomes, please refer to the risk factors set forth in the “Risk Factors” section of the Final Offering Circular. We assume no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or circumstances, or changes in the Company’s expectations, except as may be required by law. Although the Company believes that the expectations expressed in these forward-looking statements are reasonable, it cannot assure you that such expectations will turn out to be correct, and the Company cautions investors that actual results may differ materially from the anticipated results.

 

CONTACT:

Joe Dorame, Joe Diaz & Robert Blum

Lytham Partners, LLC

602-889-9700

soly@lythampartners.com

 

Source: Soliton, Inc.

About Soliton, Inc.


 

Company Overview

 

Soliton, Inc. is a medical device company with a novel and proprietary platform technology licensed from MD Anderson. The Company’s first commercial product uses rapid pulses of designed acoustic shockwaves to dramatically accelerate the removal of unwanted tattoos. The Company is based in Houston, Texas, and is actively engaged in bringing this device to the market. The Company expects to file for premarket clearance with the U.S. Food and Drug Administration (“FDA”) for its’ first device in the first quarter of 2019 and expects to receive clearance to market the device in mid 2019. This initial filing is limited to the Company’s device used in conjunction with the 1064 nm Q-switched laser to enable effective multiple pass laser treatments in a single office session to accelerate removal of black tattoos on the arms, legs and torso in Fitzpatrick Skin Type I-III individuals. While the Company believes its’ technology has many potential applications, the Company has initially focused on the removal of tattoos, where both animal and human studies have shown promising results. The current standard of care for tattoo removal is to use a Q-switched (pulsed) laser to ablate the tattoo ink particles into pieces small enough for the body’s natural processes to remove them. Unfortunately, this current method is highly inefficient, requiring up to 10 or more office visits to achieve acceptable results. A clinical trial has demonstrated that using the Company’s RAP device, in conjunction with a Q-switched laser, has the potential to produce similar results in just 2 to 3 office visits. The Company believes this “Soliton” method can not only dramatically accelerate tattoo removal, but also has the potential to lower removal cost for patients, while increasing profitability to practitioners, and to reduce the potential for unwanted side effects from current laser removal methods.

 

Soliton is developing breakthrough acoustic shockwave technology to address multiple multibillion-dollar market opportunities.

 

Our clinically proven Rapid Acoustic Pulse (RAP) device uses proprietary acoustic shockwaves to dramatically accelerate the removal of tattoos. We’ve also recently discovered that our device may have the potential to reduce cellulite and blast apart fat cells.

We are science-driven and led by executives and medical advisors from some of the world’s most successful aesthetic and medical device companies.  Let us show you our plans to revolutionize the aesthetics industry.

 

We’ve spent over 25 million dollars over the past 5 years developing a breakthrough technology that dramatically accelerates the removal of tattoos. Our devices use very high energy, in the range of 3,000 volts at nearly 3,000 amps, to form acoustic shockwaves at 100 times per second. Our core team is comprised of life science veterans, with more than 150 years of life science experience, multiple device clearances, and multiple national and international aesthetic device launches.

 

Clinically Focused

 

We’re committed to holding our technology and its applications to the highest scientific standards, including ongoing clinical trials for current and future applications. We also believe in education and transparency, and as you’ll see in our trials section, we explain what makes up a comprehensive clinical trial, and showcase our data. We continue to conduct clinical trials for tattoo removal and we are expanding our clinical trial activities to include cellulite and other aesthetic indications.

 

For Clinicians

 

Soliton’s technology is science-driven, supported by extensive preclinical and clinical research.

 

We have spent $25 million over the last 5 years understanding the biomechanics of tattoos and why short-pulse lasers have such limited efficacy in tattoo removal.  We also understand that, in order for tattoo removal to become an attractive and growing part of your practice, you need to be able to offer faster, more predictable outcomes at an affordable price.

 

Our research resulted in a breakthrough discovery of what limits the efficacy of lasers in tattoo removal.  That discovery was introduced at the 2017 ASLMS Conference and the dramatic clinical implications were expanded at the 2017 Controversies and Conversations Symposium. The Soliton Multi-Pass treatment protocol combines your existing short-pulse laser with our RAP (Rapid Acoustic Pulse) Device, facilitating multiple Laser and Soliton treatments in a single treatment session to rapidly accelerate tattoo fading.  A tattoo that would normally require 10 or more treatment sessions over a period of 1-2 years may now be removed in just 2-3 treatment sessions.

 

Our Technology

 

The combination of non-focused, very short rise-time, acoustic shock waves delivered at very high repetition rates required the creation of an entirely new acoustic technology, resulting in 9 different patent applications from our team of scientists and engineers.

 

Our acoustic waves deliver a treatment that is virtually painless, generates no heat or collateral tissue damage, and works without regard to tattoo color. Laser efficacy is enhanced, allowing for immediate second or third laser passes in the same treatment session.

 

The combination of non-focused, very short rise-time, acoustic shock waves delivered at very high repetition rates required the creation of an entirely new acoustic technology, resulting in 9 different patent applications from our team of scientists and engineers.

 

Our acoustic waves deliver a treatment that is virtually painless, generates no heat or collateral tissue damage, and works without regard to tattoo color. Laser efficacy is enhanced, allowing for immediate second or third laser passes in the same treatment session.

 

The Situation Today

 

The global growth in tattoo incidence is without dispute, as is the growth in tattoo removal. While laser removal therapy holds the largest share of this removal market, patient concerns growing from dissatisfaction with the therapy due to the unexpected, and often unpredictable, number of treatments, the resulting cost and months/years to achieve successful removal, patient discomfort, and post-treatment complications have hampered growth in the removal market.

 

The Patient Experience

 

In a proprietary research study conducted in 2014, only 10% of those beginning tattoo removal procedures completed all the recommended treatment sessions. Recent innovations in laser devices, notably the introduction of picosecond technology, represent opportunities for improvement but come with a significant price tag. Fundamentally, the greatest growth opportunity rests in the ability to provide safe, predictable, effective, fast tattoo removal therapies for the lowest incremental cost, both to the clinician as well as the patient.

 

Soliton Multi-Pass Therapy: The Benefits

 

In a pivotal multi-visit human trial, the Soliton Multi-Pass Therapy outperformed laser-only tattoo removal in 100% of the patients. The Soliton Multi-Pass Therapy resulted in an average tattoo fading of 80% vs 44% in laser-only therapy after only 2 office visits. Further, 100% of patients achieved complete removal (75% or greater) in just 2 or 3 office visits

 

Our focus? Technology to enable clinicians to provide an ideal patient experience.

 

Technology & Trials

 

We have conducted multiple clinical trials, including human trials, conducted under IRB supervision. Following additional trials we will conduct a limited product release to Key Opinion Leaders within the dermatology community. By 2020, Soliton will launch the acoustic shockwave technology into wider domestic US, followed by international, distribution and position the technology as the standard of care for tattoo removal.

 

Acoustic Wave Technology

 

 

Electro-hydraulics

 

– 3000 volts at 3000 amps

– Creates audio waves from 2 to 6 MPa @ 100 Hz

 

Electronic wave shaping

– Reduces electrode wear normally associated with electro-hydraulics

– Reduces unwanted frequencies that cause heat and pain

 

Custom designed reflector

– Eliminates cavitation, heat and pain

– Non-focused, slightly diverging waves

 

Source:  https://www.soliton.com/

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