Axonics

Press Release.

IRVINE, Calif.–(BUSINESS WIRE)– Axonics Modulation Technologies, Inc. (NASDAQ: AXNX), a medical technology company that has developed and is commercializing novel implantable rechargeable sacral neuromodulation (“SNM”) devices for the treatment of bladder and bowel dysfunction, today announced the approval of the Axonics r-SNM® System by the United States Food & Drug Administration (“FDA”) for the clinical indications of overactive bladder (“OAB”) and urinary retention.

The FDA premarket approval (“PMA”) grants Axonics the right to market its product in the United States for the clinical indications of OAB (urinary urge incontinence and urinary urge frequency) as well as urinary retention, representing the largest segment of the market for SNM devices. The FDA approval follows the Company’s September approval for the clinical indication of fecal incontinence, which, according to published clinical studies, is a co-morbidity reported by as many as a third of patients presenting with urinary urge incontinence.

The FDA approval was supported by the results of a detailed review of technical data and the positive results of the Axonics ARTISAN-SNM 129-patient pivotal clinical study that met all primary and secondary endpoints and demonstrated 90% efficacy for all implanted urinary incontinence patients at six months, as well as published clinical literature.

The Axonics r-SNM System is the first rechargeable SNM system approved for sale in the U.S., Europe, Canada and Australia. It is also the only SNM device approved for patients to undergo full-body MRI scan without the necessity of having the device explanted. The FDA approval includes the claim of a 15-year functional life, which is in contrast to the incumbent company’s legacy device which requires replacement on average every four years. In addition to many other differentiating attributes, the system includes a patented tined lead, user-friendly accessories, such as a wireless charging system optimized for infrequent charging, a small easy-to-use key-fob patient remote control and an intuitive clinician programmer that facilitates lead placement and stimulation programming. The long-lived miniaturized neurostimulator is approximately the size of a USB stick.

“If we consider the millions of women who have tried and discontinued OAB pharmaceuticals, the market opportunity for Axonics goes well beyond the approximate $700 million of revenue that is currently being generated by the incumbent’s non-rechargeable SNM device,“

said Raymond W. Cohen, CEO of Axonics.

”Based on feedback from U.S. physicians, we believe the SNM market is poised to dramatically expand over the next few years given our fuss-free, highly efficacious, long-lived, full-body MRI compatible device. Our U.S. commercial team of 146 territory managers, clinical support specialists and sales managers rivals the size of the incumbent’s field staff, and is focused on calling on the top 1,000 urologists, urogynecologists and colorectal surgeons who account for approximately 80% of the SNM implants in the U.S.”

As previously announced, Axonics is hosting a conference call with the investment community today, Thursday, November 14, 2019, at 4:30 p.m. Eastern Time to discuss 2019 third quarter financial results and recent business developments.

Interested parties may access the live call via telephone by dialing (866) 687-5771 (U.S.) or (409) 217-8725 (International) and using passcode 4373989. A live webcast of the call may be accessed by visiting the Events & Presentations page of the investors section of the Company’s website at ir.axonicsmodulation.com.

ARTISAN-SNM pivotal study and the PMA approval process with the U.S. FDA

ARTISAN-SNM was conducted at 14 centers in the U.S. and five centers in Western Europe. The study met all primary and secondary endpoints and demonstrated that implanted patients received clinically meaningful and statistically significant improvements in urinary incontinence symptoms and quality of life. At the study endpoint of six months post-implant, 90% of all 129 implanted patients were therapy responders. At one year, the efficacy remained consistent with an 89% responder rate. The vast majority of implanted patients experienced a significant reduction in urgency incontinence episodes and approximately one third were completely dry. No serious device-related adverse events were reported.

After the initial filing in December 2018, the Company filed a number of amendments, including complete test data to support full-body MRI labeling for the implantable components of the Axonics r-SNM System and the full six-month data set from its pivotal study. The FDA conducted two detailed PMA audits of the Axonics quality system and manufacturing during the review period. The audits were completed without any negative observations.

About Axonics Modulation Technologies, Inc. and Sacral Neuromodulation

Axonics, based in Irvine, Calif., has developed and is commercializing novel implantable SNM devices for patients with urinary and bowel dysfunction. These conditions are caused by a miscommunication between the bladder and the brain and significantly impacts quality of life. Overactive bladder affects an estimated 87 million adults in the U.S. and Europe. Another estimated 40 million adults are reported to suffer from fecal incontinence/accidental bowel leakage. SNM therapy has been employed to reduce symptoms and restore pelvic floor function for the past two decades. Reimbursement coverage is well established in the U.S. and Europe. The Axonics System is the first rechargeable SNM system approved for sale in the world, and the first to gain full-body MRI conditional labeling. For more information, visit the Company’s website at www.axonics.com.

Forward-Looking Statements

Statements made in this press release that relate to future plans, events, prospects or performance are forward-looking statements as defined under the Private Securities Litigation Reform Act of 1995. Words such as “planned,” “expects,” “believes,” “anticipates,” “designed,” and similar words are intended to identify forward-looking statements. While these forward-looking statements are based on the current expectations and beliefs of management, such forward-looking statements are subject to a number of risks, uncertainties, assumptions and other factors that could cause actual results to differ materially from the expectations expressed in this press release, including the risks and uncertainties disclosed in Axonics filings with the Securities and Exchange Commission, all of which are available online at www.sec.gov. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Except as required by law, Axonics undertakes no obligation to update or revise any forward-looking statements to reflect new information, changed circumstances or unanticipated events.

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Contacts

Axonics’ Contact
Axonics Modulation Technologies, Inc.
Dan Dearen, +1-949-396-6320
President & Chief Financial Officer
ir@axonics.com

Investor & Media Contact
W2Opure
Matt Clawson, +1-949-370-8500
mclawson@w2ogroup.com

Source: Axonics Modulation Technologies, Inc.

Press Release.

IRVINE, Calif.–(BUSINESS WIRE)– Axonics Modulation Technologies, Inc. (NASDAQ: AXNX), a medical technology company that has developed and is commercializing a novel implantable rechargeable sacral neuromodulation (“SNM”) device for the treatment of urinary and bowel dysfunction, today announced the approval of the Axonics r-SNM® System by the United States Food & Drug Administration (“FDA”). The Axonics System is the first rechargeable SNM system approved for sale in the United States, Europe, Canada and Australia.

The FDA approval grants Axonics the right to market its product in the United States for the clinical indication of fecal incontinence. The approval includes the claim of a 15-year functional life and the ability of patients to undergo full-body MRI scans without the necessity of having the device explanted.

Axonics has an additional pre-market approval (“PMA”) filing currently under review with the FDA for the clinical indications of overactive bladder (urinary urgency incontinence and urinary urgency frequency) as well as urinary retention for which the Company anticipates a determination in the near term.

Raymond W. Cohen, CEO of Axonics, commented,

“If we consider the millions of women who are suffering in silence with bladder and bowel dysfunction, we believe the market opportunity for Axonics goes well beyond the existing approximately $650 million of revenue that is currently being generated by the incumbent’s non-rechargeable SNM device. We believe the number of patients seeking SNM treatment will expand dramatically over the next few years given our fuss-free, long-lived, full body MRI-compatible device. In the months prior to FDA approval, we invested significant time and resources in building inventory to support our fully trained, U.S. commercial team which now includes 145 territory managers, clinical support specialists and sales managers strategically located around the country. We plan to begin shipping product to U.S. physicians and hospitals during the fourth quarter of 2019, following the fulfillment of customary, pre-launch regulatory requirements.”

About Sacral Neuromodulation and the Axonics r-SNM System

Sacral neuromodulation is used to treat bladder and bowel dysfunction. These conditions are caused by a miscommunication between the bladder and the brain and significantly impacts quality of life. Overactive bladder affects an estimated 87 million adults in the U.S. and Europe. Another estimated 40 million adults are reported to suffer from fecal incontinence/accidental bowel leakage. SNM therapy has been employed to reduce symptoms and restore pelvic floor function for the past two decades. Reimbursement coverage is well established in the U.S. and Europe. The Axonics r-SNM System is the first rechargeable SNM system approved for sale in the world, and the first to gain full-body MRI conditional labeling. The Axonics r-SNM System offers a long-lived miniaturized neurostimulator that is approximately the size of a USB stick and is qualified to last 15 years in the body as compared to the incumbent’s device which is non-rechargeable and requires patients to undergo a surgical intervention to replace the device every 3 to 5 years. In addition to full body MRI conditional labeling, the Axonics r-SNM System features many differentiating attributes. These include a patented tined lead, user-friendly accessories, a wireless charging system optimized for infrequent charging, a small easy-to-use patient remote control and an intuitive clinician programmer that facilitates lead placement and stimulation programming.

PMA approval process with the U.S. FDA

Determination by the FDA of the safety and effectiveness of the Axonics r-SNM System was supported by the results of a detailed review of technical data, published SNM clinical literature and the ARTISAN-SNM 129-patient pivotal clinical study. ARTISAN-SNM was conducted at 14 centers in the U.S. and five centers in Western Europe and met all primary and secondary endpoints. No serious device-related adverse events were reported. During the review period the FDA conducted two detailed PMA audits of the Axonics quality system and manufacturing. The audits were completed without any negative observations.

Conference Call and Webcast

The Company will host a conference call with the investment community to discuss the FDA approval and recent business developments, on September 9, 2019, at 9:00 a.m. Eastern Time.

Interested parties may access the live call via telephone by dialing (866) 687-5771 (U.S.) or (409) 217-8725 (International) and using passcode 3147028. A live webcast of the call may be accessed by visiting the Events & Presentations page of the investors section of the Company’s website at ir.axonicsmodulation.com. A replay of the webcast will be available shortly after the conclusion of the call and will be archived on the Company’s website for 90 days.

About Axonics Modulation Technologies, Inc.

Axonics, based in Irvine, CA, has developed and is commercializing a novel implantable SNM device for patients with urinary and bowel dysfunction. For more information, visit the Company’s website at www.axonicsmodulation.com

Forward-Looking Statements

Statements made in this press release that relate to future plans, events, prospects or performance are forward-looking statements as defined under the Private Securities Litigation Reform Act of 1995. Words such as “planned,” “expects,” “believes,” “anticipates,” “designed,” and similar words are intended to identify forward-looking statements. While these forward-looking statements are based on the current expectations and beliefs of management, such forward-looking statements are subject to a number of risks, uncertainties, assumptions and other factors that could cause actual results to differ materially from the expectations expressed in this press release, including the risks and uncertainties disclosed in Axonics filings with the Securities and Exchange Commission, all of which are available online at www.sec.gov. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Except as required by law, Axonics undertakes no obligation to update or revise any forward-looking statements to reflect new information, changed circumstances or unanticipated events.

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Contacts

Axonics’ Contact
Axonics Modulation Technologies, Inc.
Dan Dearen, +1-949-396-6320
President & Chief Financial Officer
ir@axonics.com

Investor & Media Contact
W2Opure
Matt Clawson, +1-949-370-8500
mclawson@w2ogroup.com

Source: Axonics Modulation Technologies, Inc.

Press Release.

IRVINE, Calif.–(BUSINESS WIRE)–Feb. 22, 2019– Axonics Modulation Technologies, Inc. (NASDAQ: AXNX), a medical technology company focused on the development and commercialization of novel implantable Sacral Neuromodulation (“SNM”) devices for the treatment of urinary and bowel dysfunction, announced today that it has received CE mark approval for 1.5T and 3T full-body magnetic resonance imaging (“MRI”) conditional labeling for the Axonics r-SNM® System.

The Axonics r-SNM System is the only implantable SNM system that has received full-body MRI conditional labeling for sale in Europe1.

Raymond W. Cohen, Chief Executive Officer of Axonics, said,

“Without this labeling, any patient requiring an MRI scan on any body part below the head must have their neurostimulator surgically explanted prior to the MRI scan, resulting in an additional surgery for the patient and additional costs to patients and the healthcare system. This authorization of full-body MRI scans in Europe is another important milestone for Axonics, differentiating our technology from the competitive system and further demonstrating the foresight of our engineers and our commitment to invest the time and capital to provide the best possible SNM solution for patients, clinicians and the healthcare system. As announced on February 12, Axonics submitted complete test data to the U.S. FDA for the purpose of gaining Conditional Full Body Magnetic Resonance Imaging labeling approval in the U.S.”

Full-body MRI labeling is a significant addition to the many differentiating attributes already offered by the Axonics r-SNM product: a miniaturized and long-lived implantable neurostimulator that is one-third the size of the only competitor and is qualified to last at least 15 years in the body. The Axonics r-SNM System also features, among other things, a fast and safe charging capability with an infrequent charging interval, and a patient-friendly wireless remote control.

“This is a game changer,”

said Karen L. Noblett, M.D., Chief Medical Officer of Axonics.

“Full-body MRI labeling is critical to patients who need, or may anticipate needing, magnetic resonance imaging. This new expanded labeling eliminates a major concern for both groups of patients and will allow more patients to choose SNM to treat their urinary and bowel dysfunction without compromising their quality of life.”

What is MRI Conditional Labeling
MRI is short for Magnetic Resonance Imaging. MR scanners come in different magnet field strengths measured in Tesla or “T”, usually between 0.5T and 3.0T. They also come in varying sizes including open and wide-bore. Simplistically, an MR scanner is a very large, strong magnet into which a patient lies. A radio wave is used to send signals to the body of the patient. The returning signals are received and converted into images by a computer attached to the MR scanner. The image quality of an MRI depends on signal and field strength. MRI Conditional Labeling means a product has been tested and demonstrated to pose no known hazards to the patient in a specified MRI environment with specified conditions of use and the results of testing are sufficient to characterize the behavior of the product in the MRI environment. Testing for devices that may be placed in the MRI environment should address magnetically induced displacement force and torque, unintended stimulation, and thermal injury. Other possible safety issues include but are not limited to, image artifact, device vibration, interaction among devices, the safe functioning of the device and the safe operation of the MRI system. Any parameter that affects the safety of the device should be listed and any condition that is known to produce an unsafe consequence must be described.

About Overactive Bladder and Sacral Neuromodulation
Overactive bladder (OAB) includes urinary urge incontinence and urinary frequency and affects an estimated 85 million adults in the U.S. and Europe. OAB is caused by a miscommunication between the bladder and the brain and significantly impacts quality of life. SNM therapy is a well-established treatment that has been widely employed to reduce symptoms and restore bladder function and is also employed to treat urinary retention and fecal incontinence. Reimbursement for SNM is well established in the United States and is a covered service in Europe, Canada and Australia.

About Axonics Modulation Technologies, Inc.
Axonics, based in Irvine, CA, is focused on development and commercialization of a novel implantable SNM system for patients with urinary and bowel dysfunction. The Axonics r-SNM System is the first rechargeable Sacral Neuromodulation system approved for sale in Europe, Canada and Australia. The r-SNM System offers a temporary disposable external trial system, a miniaturized and rechargeable long-lived stimulator that is qualified to function for at least 15 years. Also included is a tined lead, as well as patient-friendly accessories such as a charging system optimized for minimal charge time without overheating, a small, easy to use patient remote control and an intuitive clinician programmer that facilitates lead placement and programming. For more information, visit the Company’s website at www.axonicsmodulation.com.

Forward-Looking Statements
Statements made in this press release that relate to future plans, events, prospects or performance are forward-looking statements as defined under the Private Securities Litigation Reform Act of 1995. Words such as “planned,” “expects,” “believes,” “anticipates,” “designed,” and similar words are intended to identify forward-looking statements. While these forward-looking statements are based on the current expectations and beliefs of management, such forward-looking statements are subject to a number of risks, uncertainties, assumptions and other factors that could cause actual results to differ materially from the expectations expressed in this press release, including the risks and uncertainties disclosed in Axonics filings with the Securities and Exchange Commission, all of which are available online at www.sec.gov. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Except as required by law, Axonics undertakes no obligation to update or revise any forward-looking statements to reflect new information, changed circumstances or unanticipated events.

1 The Axonics r-SNM System is approved for sale in Europe, Canada and Australia. It currently is designated as an investigational medical device in the U.S.

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Source: Axonics Modulation Technologies, Inc.

Axonics’ Contact
Axonics Modulation Technologies, Inc.
Dan Dearen, +1-949-396-6320
President & Chief Financial Officer
ir@axonics.com

Investor & Media Contact
W2Opure
Matt Clawson, +1-949-370-8500
mclawson@w2ogroup.com

Press Release.

October 31, 2018

IRVINE, Calif.–(BUSINESS WIRE)–Oct. 30, 2018– Axonics Modulation Technologies, Inc. (“Axonics”), a medical technology company focused on the design, development and commercialization of innovative and minimally invasive sacral neuromodulation (“SNM”) solutions for the treatment of overactive bladder (“OAB”), fecal incontinence (“FI”), and urinary retention (“UR”), today announced the pricing of its initial public offering of
8,000,000 shares of common stock at an initial public offering price of $15.00 per share, before underwriting discounts and commissions. Axonics has also granted the underwriters a 30-day option to purchase an additional 1,200,000 shares of common stock at the initial public offering price, less underwriting discounts and commissions. All of the shares of common stock are being offered by Axonics.

The shares of Axonics’ common stock have been approved for listing on The Nasdaq Global Select Market and are expected to begin trading under the ticker symbol “AXNX” on October 31, 2018. The offering is expected to close on November 2, 2018, subject to customary closing conditions.

BofA Merrill Lynch and Morgan Stanley are acting as joint book-running managers for the offering. Wells Fargo Securities is acting as lead manager and SunTrust Robinson Humphrey is acting as co-manager for the offering.

A registration statement on Form S-1, including a prospectus, which is preliminary and subject to completion, relating to the offering has been filed with, and declared effective by, the U.S. Securities and Exchange Commission on October 30, 2018. The offering of these shares is being made only by means of a prospectus. Copies of the prospectus may be obtained from BofA Merrill Lynch, NC1-004-03-43, 200 North College Street, 3rd Floor, Charlotte, NC 28255-0001, Attention: Prospectus Department, or by email at dg.prospectus_requests@baml.com; or Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, 2nd Floor, New York, NY 10014.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these 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 any such state orjurisdiction.

About Axonics Modulation Technologies, Inc.

Axonics has developed an innovative rechargeable SNM system for the treatment of patients with OAB, FI, and UR. Axonics’ proprietary r-SNM System is designed to be 60% smaller than existing technology and to last approximately 15 years. Axonics currently has marketing approvals in Europe, Canada, and Australia for OAB, FI, and UR.

Forward-Looking Statements

This press release contains certain forward-looking statements, including statements with regard to Axonics’ proposed initial public offering. Wordssuch as “expects,” “anticipates” and “intends” or similar expressions are intended to identify forward-looking statements. These forward-lookingstatements are subject to the inherent uncertainties in predicting future results and conditions and no assurance can be given that the proposed initial
public offering discussed above will be completed on the terms described. Completion of the proposed initial publicoffering and the terms thereof aresubject to numerous factors, many of which are beyond the control of Axonics, including, without limitation, failure of customary closing conditions andthe risk factors and other matters set forth in the prospectus included in the registration statement in the form last filed with the U.S. Securities and Exchange Commission. Axonics undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required by law.

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Source: Axonics Modulation Technologies, Inc.

Axonics’ Contacts
Axonics Modulation Technologies, Inc.
Dan Dearen, +1-949-396-6320
President & Chief Financial Officer
ddearen@axonicsmodulation.com
or
Investor & Media Contact
W2Opure
Matt Clawson, +1-949-370-8500
mclawson@w2ogroup.com

Press Release.

Irvine, CA – May 2, 2017 – Axonics Modulation Technologies, Inc., developer of the first rechargeable Sacral Neuromodulation (r-SNM™) system for the treatment of urinary and fecal dysfunction, announced today that it has completed a $14.5 million first closing of its Series C financing.

Axonics intends to raise $30 million in its Series C financing. Proceeds from the financing will be used to conduct a pivotal clinical study in Overactive Bladder patients to gain U.S. FDA approval and prepare the Company to access markets around the world. The U.S. pivotal study is anticipated to begin in the second half of 2017 in select medical centers in North America and Europe.

The Series C financing first closing was comprised of all of Axonics’ major stockholders including Edmond de Rothschild Investment Partners based in Paris, London-based Advent Life Sciences, Boston-based Cormorant Asset Management, Beijing-based Legend Capital, Geneva-based NeoMed Management, and a select group of private individuals.

“These world-class investors have provided Axonics with phenomenal support throughout the development phase of our project, including attainment of key milestones such as European and Canadian regulatory approval and completion of our 50-patient European clinical study,”

said Raymond W. Cohen, Chief Executive Officer of Axonics.

“Revenue from the sale of SNM devices is estimated at nearly $700 million in 2016 and is projected to grow to over $1 billion by 2021. With only one player in the SNM market today, our miniaturized rechargeable system represents a very attractive opportunity in the medtech space.”

About Axonics Modulation Technologies, Inc.

Axonics, based in Irvine, CA, is a privately-held venture backed company that has developed a novel implantable neuromodulation technology for patients with urinary and fecal dysfunction and can be further directed towards several clinical indications. The Axonics r-SNM System includes a miniaturized rechargeable stimulator qualified to function at least 15 years, a charging system optimized for reduced charge time and minimal heating, a patient-friendly remote control and an intuitive clinician programmer that facilitates the lead placement procedure and programming. For more information, visit the Company’s website at www.axonicsmodulation.com

Press Release.

Irvine, CA – December 21, 2015 – Axonics Modulation Technologies, Inc., developer of miniaturized implantable Sacral Neuromodulation technology, announced today that it has completed a $38.5 million Series B financing.

Proceeds from the financing will be used to conduct a multi-center clinical study in Overactive Bladder patients anticipated to begin in early 2016 in Europe and North America.

Sacral Neuromodulation therapy is FDA-approved and has been proven to be safe and effective for patients suffering from various chronic conditions, including Overactive Bladder, Fecal Incontinence and Urinary Retention. These conditions affect over 100 million adults in the world.

New investors Advent Life Sciences, based in London and Cormorant Asset Management, based in Boston, joined the existing syndicate led by Edmond de Rothschild Investment Partners of Paris, France. Existing investors NeoMed Management based in Geneva, Beijing-based Legend Capital, a venture capital arm of Legend Holdings, Ltd., Valencia, CA- based The Alfred E. Mann Foundation and a select group of private individuals also participated. Since inception in late 2013, Axonics has raised a total of $59 million in capital.

Raymond W. Cohen, Chief Executive Officer of Axonics said,

“We appreciate that this group of world-class investors recognizes the quality work done by Axonics to create a state-of-the-art rechargeable implantable Sacral Neuromodulation (SNM) System. The Axonics SNM System is 60 percent smaller than the currently marketed SNM technology and also the first rechargeable device available for this market. Moreover, our implanted pulse generator promises to last over 15 years in the body – 3x longer than the other SNM device on the market today. Revenue from the sale of SNM devices is estimated to be approaching $600 million annually with nearly 30,000 devices implanted in patients in 2014 alone. Revenue for this market is projected to grow to over $1 billion by 2019. With only one player in the SNM market today, this represents a significant opportunity for Axonics stakeholders and patients alike.”

Shahzad Malik, M.D. of Advent Life Sciences will join the Axonics Board of Directors serving alongside Chairman, Raphaël Wisniewski of Edmond de Rothschild Investment Partners and other directors including Erik Amble of NeoMed, Darren Cai of Legend, John Petrovich and Barry Keenan of The Alfred E. Mann Foundation and Axonics CEO Raymond W. Cohen.

About Overactive Bladder Syndrome (OAB) and Fecal Incontinence (FI)

OAB is a chronic medical condition that significantly affects patients’ quality of life and often persists for many years. It is estimated that 85 million patients in Europe and the US suffer from OAB and another 40 million suffer from FI. OAB costs an estimated $65 billion every year to the US alone, including direct and indirect costs for physician visits, surgery, nursing home care, incontinence pads, drug therapy, comorbidities and lost productivity. OAB significantly affects quality of life, frequently resulting in depression, social isolation, comorbidities and significant life-style alteration. It is reported that over 3 million people are refractory to drugs and seek third line treatment options. Fecal Incontinence costs an estimated $75 billion every year to the US, including direct and indirect costs. FI is also a primary cause for institutionalization concerning up to 50 percent of nursing home patients. An estimated 2 million patients seek advanced treatment options.

About Sacral Neuromodulation (SNM)

SNM, which is an FDA-approved therapy to treat urinary and fecal dysfunction, is an implantable device-based treatment that delivers adjustable electrical stimulation to a target area of the sacral nerve. After behavioral interventions and medications as first- and second-line treatments, respectively, SNM (also called sacral nerve stimulation) has emerged as a guideline-recommended third-line treatment for OAB. A significant body of evidence demonstrates that patients treated with SNM have therapeutic success and sustained relief of symptoms and improvement in quality of life. The American Urological Association recommends SNM for OAB patients who have not responded to second-line treatment (drugs). SNM is recommended by the American College of Gastroenterology for FI patients who have not responded to conservative treatment. SNM benefits from broad reimbursement coverage in the US and Europe.

About Axonics Modulation Technologies, Inc.

Axonics, based in Irvine, CA, is a privately held venture-backed pre-revenue company that has developed a novel implantable neuromodulation technology. The Company was founded in October 2013 based on a license to numerous fields of use from the Alfred E. Mann Foundation of 19 issued patents directed toward neuromodulation technology.

About Advent Life Sciences

Advent Life Sciences founds and invests in early- and mid-stage life sciences companies that have a first- or best-in-class approach to unmet medical needs. The investing team consists of 16 professionals, each with extensive scientific, medical and operational experience, a long-standing record of entrepreneurial and investment success in the US and Europe, and is particularly focused on supporting entrepreneurs and founders to take innovative new medical entities from concept to approval. The Firm invests in a range of sectors within life sciences, principally drug discovery, enabling technologies and med tech, always with an emphasis on innovative, paradigm-changing approaches. Advent Life Sciences has a presence in the UK, US and France. For more information, please visit www.adventLS.com

About the Alfred Mann Foundation

Founded in 1985 by serial healthcare entrepreneur Alfred E. Mann, AMF is a non-profit medical research organization whose mission it is to bring advanced medical technologies to the public. AMF has developed a myriad of medical devices that have changed the lives of patients across the globe, including cochlear implants that enable deaf people to hear, implantable myoelectric sensors that enable amputees to control robotic prosthetics with their thoughts alone, several diabetes products as well as numerous products in the neural space for management of pain and the recovery of lost muscle function.

About Cormorant Asset Management

Boston-based Cormorant Asset Management is a biotech focused investment firm that was founded in 2013. With over $800 million in assets under management, Cormorant invests in both public and private companies in the biopharmaceutical, medical device and life science research tool fields. Cormorant looks to participate in financings that will enable the company to achieve their first key proof of concept and thereafter allow the company to attract growth capital. In both public and private companies, Cormorant supports innovation that will in the long run add great value to patient lives and healthcare system.

About Edmond de Rothschild Investment Partners

Paris-based Edmond de Rothschild Investment Partners is a leading investor in minority investments into privately owned companies. Affiliate of the Edmond de Rothschild Group, the fund management employs 41 employees and has approximately €1.3 billion under management. Its life sciences team of nine professionals brings together over 60 years of experience in the life science industry and more than 100 years of private equity and venture capital experience. The team has raised more than €450 million through its Biodiscovery franchise and is currently completing the investment of BioDiscovery 4 fund. Since their inception, BioDiscovery Funds have invested in 53 privately held companies, of which 15 have been sold and 14 listed on public financial markets, while 21 are active in the portfolios. BioDiscovery Funds, including BioDiscovery 4, are venture capital funds dedicated to professional investors. These funds are not authorized by the Autorité des Marchés Financiers and may adopt special investment rules. For more information, please visit: www.edrip.fr

About Legend Capital

Legend Capital, based in Beijing, China, focuses on early and expansion-stage venture capital investments with 20 partners managing five USD funds and two RMB funds with over $2 billion focused on innovation and growth enterprises primarily related to China. Legend Capital has invested in nearly 200 companies, of which 23 are already listed on the NYSE, NASDAQ, HKEx, Gretai Securities Market, Shanghai Stock Exchange, GEM and ChiNext of Shenzhen Stock Exchange, with an additional 13 exits through trade-sale. In the Healthcare and Life science sector, Legend Capital has invested in over 20 companies in recent years with outstanding growth trajectory in China and/or a clear China market entry strategy. For more information please visit: www.legendcapital.com.cn

About NeoMed Management

NeoMed Management is an international investment firm registered in Jersey, Channel Islands, with total capital under management in excess of $300 million that focuses exclusively on the healthcare products industry. NeoMed invests in all stages of development from start-up to later stage growth. Since inception in 1997, NeoMed has successfully invested in more than 40 innovative European and North American companies with outstanding growth prospects. For more information please visit: www.neomed.net