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Axonics, Outset lead medtech space on Deloitte’s list of fastest growing companies

Deloitte today released its “North America Technology Fast 500” list of growing companies, including a handful of medtech firms.

The list, which ranking of the fastest-growing North American companies across a range of sectors, included several “Life Sciences” outfits. Immunology company Vir Biotechnology led the way in first place on the list.

Axonics (Nasdaq:AXNX) represented the highest-ranked medical device company at No. 4. According to Deloitte, the company registered 25,401% growth over a three-year period. Axonics reported $180.3 million in revenue in fiscal 2021, compared to $707,000 in fiscal 2018.

The company topped last year’s version of the list. Axonics develops novel products for adults with bladder and bowel dysfunction. Its sacral neuromodulation (SNM) systems provide adults suffering from overactive bladder and/or fecal incontinence with long-lived, easy-to-use, safe, clinically effective therapy. The compa…

Axonics stock dips after hours despite Street-beating Q3, raised guidance

Axonics (Nasdaq:AXNX) shares took a hit after hours despite third-quarter results that bettered the consensus forecast.

Shares of AXNX dipped 7% to $68 apiece after the market closed. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — finished the day up 0.2%.

The Irvine, California-based sacral neuromodulation (SNM) technology developer posted losses of $16.3 million. It reported sales of $70.4 million for the three months ended Sept. 30, 2022.

Axonics produced a slight bottom-line gain despite remaining in the red on sales growth of 50%. Its losses per share of 34¢ beat Wall Street expectations by 14¢. Meanwhile, sales topped the analysts’ expectations of $63 million.

The company reported sales of $56.9 million from its sacral neuromodulation business. The remaining $13.5 million came from sales of Bulkamid, a urethral bulking hydrogel.

“This quarter’s record revenue …

Axonics announces first patient implants in Canada for sacral neuromod system

Axonics (Nasdaq:AXNX) today announced the first patient implants in Canada for its Axonics F15 sacral neuromodulation (SNM) system.

Irvine, California-based Axonics designed its new F15 as a long-lived, fully recharge-free SNM system. It received Health Canada approval after FDA approval in March. The company’s U.S. launch took place the following month.

According to a news release, the University of Alberta implanted four patients with F15 this week. The patients were programmed at stimulation amplitudes between 0.95mA and 0.30mA. The resulting expected battery longevity ranges from 18 years to more than 22 years.

“The approval of the Axonics recharge-free system is welcome news for patients in Canada suffering from bladder and bowel dysfunction,” said Dr Gary J. Gray, a urologist and clinical professor at the Kipnes Urology Centre in the Department of Surgery at the University of Alberta. “I am excited to now offer patients a recharge-free option…

10 big earnings stories from the last quarter: How are medtech stocks doing now?

(From Ishant Mishra on Unsplash)

Economic uncertainty appears to have produced a wide variety of medtech earnings stories during the most recent round of quarterly results.

Some medical device companies received massive boosts from their quarterly performance, while others saw their stocks sink amid missed projections and other various issues. The phrase “macroeconomic headwinds” was a common phrase. Medtech faces a strong U.S. dollar (a hurdle for American companies selling overseas), supply chain disruption and inflation.

For all of MassDevice’s medtech earnings stories, click HERE

MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — has mostly been on the rise over this period, getting as high as $90.10 per share (a 6.5% increase from the price of $84.60 at the start of the period). It is now at $85.27 for the last month, representing a 0.7% r…

Axonics expands IP portfolio with new patents

Axonics (Nasdaq:AXNX) announced today that it has been granted eight patents and allowed a further four applications in the past 12 months.

Irvine, California-based Axonics eight granted patents and four applications to the U.S. Patent and Trademark Office relate to its portfolio of sacral neuromodulation (SNM) technology.

According to a news release, the patents represent technology internally developed by the company, including the Axonics external trial system, tined lead, implantable neurostimulator, clinician programmer, wireless charging system and patient remote control.

“Axonics is committed to developing best-in-class technology to serve the unmet needs of the millions of adults suffering from incontinence. The volume, subject matter diversity, and breadth of these patents demonstrate the investment in innovation that Axonics continues to make in sacral neuromodulation technology,” said Axoncis CEO Raymond W. Cohen.

The granted U.S. paten…

Axonics stock ticks up on Street-beating Q2, increased guidance

Axonics (Nasdaq:AXNX) shares are on the rise today on second-quarter results that came in ahead of the consensus forecast.

The Irvine, California-based sacral neuromodulation technology developer posted losses of $34.1 million, or 47¢ per share, on sales of $69 million for the three months ended June 30, 2022, for a nearly $10 million bottom-line slide further into the red on sales growth of 50.4%.

Axonics’ losses per share of 47¢ came in 7¢ ahead of expectations on Wall Street, where analysts were looking for sales of $60.1 million.

In a news release, CEO Raymond W. Cohen said the quarterly results — which include a record revenue total — reflect the growing demand for the company’s incontinence solutions, with sacral neuromodulation sales growing 39% year-over-year thanks in large part to the April launch of the F15 recharge-free sacral neuromodulation system. Additionally, the Bulkamid system for stress urinary incontinence symptoms produc…

Axonics files FDA PMA supplement for 4th-gen rechargeable neurostimulator

Axonics (Nasdaq:AXNX) announced that it filed a premarket approval (PMA) supplement with the FDA for its next-generation neurostimulator.

Irvine, California-based Axonics designed its fourth-generation rechargeable sacral neuromodulation implantable neurostimulator (INS) to reduce the frequency with which a patient needs to recharge their implanted device to just once every six months for one hour.

The current recharging interval comes once per month for one hour with Axonics’ third-generation rechargeable INS, according to a news release.

Axonics’ latest INS utilizes the same small 5cc form factor as its R15 system and pairs with the same tined lead and intuitive, easy-to-use patient remote control. The company expects the INS to receive FDA labeling for 20 years of useful life in the body, with projections for FDA approval set for the fourth quarter of 2022, followed by shipment of the new device to customers in the first quarter of 2023. Read more

Axonics raises 2022 sales guidance on Street-beating Q1

Axonics Modulation Technologies (Nasdaq:AXNX) reported first-quarter financial results that topped analysts’ consensus forecast.

The Irvine, California-based sacral neuromodulation technology developer posted losses of $22.7 million, or 50¢ per share, on sales of $48.4 million for the three months ended March 31, 2022, for a slight bottom-line loss of just over $150,000 year-over-year on sales growth of 40.9%.

Axonics’ losses per share of 50¢ came in 13¢ ahead of projections on Wall Street, where analysts were looking for sales of $45.4 million.

“We are pleased with this quarter’s revenue result considering the significant impact the Omicron surge had on elective procedures in January and February,” Axonics CEO Raymond W. Cohen said in a news release. “Sacral neuromodulation procedure volumes recovered nicely in March and continued to trend favorably in April. Bulkamid generated yet another quarter of record revenue and we are delighted to re…

Axonics launches F15 recharge-free sacral neuromodulation system

Axonics (Nasdaq:AXNX) announced today that it launched its F15 recharge-free sacral neuromodulation (SNM) system in the U.S.

Irvine, California-based Axonics received FDA approval for the F15 SNM system in March.

The company designed the newly developed F15 recharge-free SNM system to feature a functional life span of over 15 years at typical stimulation parameters, with the capacity to last more than 2 decades at lower-energy settings.

Axonics said in a news release that the 10 cubic centimeter size of the F15 system makes it 20% smaller than the market’s other non-rechargeable SNM device, while it has compatibility for full-body MRI with 1.5T and 3.0T whole-body scanners.

The F15 system’s proprietary algorithm recommends optimal stimulation parameters based on intraoperative responses, while its constant current automatically adjusts stimulation output. The platform features an intuitive, recharge-free key fob control with SmartMRI t…

FDA clears Axonics’ recharge-free sacral neuromodulation system

Axonics Modulation Technologies (Nasdaq:AXNX) announced today that it received FDA approval for its new implantable neurostimulator.

Irvine, California-based Axonics designed the Axonics F15 recharge-free sacral-neuromodulation (SNM) system with a functional life span of over 15 years at typical stimulation parameters and over 20 years at lower-energy settings.

The system’s size totals 10 cubic centimeters, making it 20% smaller than the market’s other non-rechargeable SNM device, Axonics said in a news release. Its constant current automatically adjusts stimulation output, while it also offers intuitive, recharge-free key fob control featuring SmartMRI technology.

Axonics’ recharge-free SNM system has MRI compatibility for full-body MRI with 1.5T and 3.0T whole-body scanners, as well as a proprietary algorithm that recommends optimal stimulation parameters based on intraoperative responses.

Axonics CEO Raymond W. Cohen said last…

Axonics ticks up on Street-beating Q4, expects recharge-free SNM launch in Q2 of 2022

Axonics Modulation Technologies (NSDQ:AXNX) shares rose today on fourth-quarter results that beat the consensus forecast on Wall Street.

The Irvine, California-based sacral neuromodulation (SNM) technology developer posted losses of $15.2 million, or 34¢ per share, on sales of $53.1 million for the three months ended Dec. 31, 2021, for a bottom-line of nearly $4 million despite sales growth of 52.8%.

Axonics’ losses per share of 34¢ came in 2¢ ahead of projections on Wall Street, where analysts were looking for sales of $50.5 million.

“We are proud of our fourth-quarter and fiscal year 2021 results considering the disruption Covid-19 has had on elective procedures in the U.S. and around the world,” Axonics CEO Raymond W. Cohen said in a news release. “In 2021, in addition to strong commercial execution, Axonics made important progress on several strategic initiatives, including the successful acquisition and launch of Bulkamid in the U.S., growth o…

Medtronic’s IP dispute against Axonics could resume in court after PTAB decisions

Medtronic (NYSE:MDT) and Axonics (NSDQ:AXNX) could see their patent dispute over neurostimulation technology resume in court.

Yesterday, the Patent Trial and Appeal Board (PTAB) of the U.S. Patent and Trademark Office affirmed an additional three patents in a long-term dispute between the companies over intellectual property for Medtronic’s Interstim sacral neuromodulation (SNM) system, completing the review process initiated by Axonics to challenge the validity of the seven total patents in the case brought by Medtronic, according to a news release.

“Medtronic appreciates the Patent Trial and Appeal Board’s efforts in this matter,” Medtronic EVP & president of the neuroscience portfolio Brett Wall said in the release. “We are pleased with the outcome of the review process and look forward to our day in court to protect the proprietary technology that brings SNM therapy to patients around the world.”

Following the …