With today’s more stringent investor requirements in mind, it’s worth taking a look at a few of the stand-out medtech investment deals completed thus far in 2024 to help identify common threads attracting investor interest.
Of the early-stage medtech rounds completed in the first half of the year, UKbased Amber Therapeutics’ huge $100 million Series A haul, which closed in June, tops the list. The company—a presenter at LSI’s 2024 Europe conference—garnered one of the largest Series A rounds ever for a European medtech.
Although the deal seems massive for a little-known company founded only three years ago, it should not be surprising given Amber’s focus on neuromodulation (one of the hottest growth areas) and women’s health (one of the most underserved), as well as its quick, cash-sparing path to the clinic (the company was founded in 2021, began its first human study in late 2022, and by early 2024 had preliminary results confirming the safety and feasibility of its technology).
The Series A raise was financed by a syndicate of US and UK investors, led by New Enterprise Associates, and including new investors F-Prime Capital, Lightstone Ventures, and corporate VC participant Intuitive Ventures, along with existing investors Oxford Science Enterprises (which operates in partnership with the University of Oxford), and 8VC.
Amber Therapeutics intends to use the proceeds to fund pilot and pivotal studies aimed at US regulatory approval for its Amber-UI device, a unique, fully implantable adaptive neuromodulation therapy for women with mixed urinary incontinence (a combination of both urge and stress incontinence).
Amber-UI targets the pudendal nerve originating from the sacral plexis in the pelvic region, and the device is implanted using a minimally invasive procedure. It is the first device of its kind aimed at urinary incontinence, a common condition that the company says impacts 40 million women in the US.
The need is clear, the firm says, since less than half of those women are being treated, and no single therapy option is currently available that can treat mixed incontinence. LSI’s Market Intelligence analysts value the global sacral stimulation market at $1.5 billion in 2023, increasing at a CAGR of 7% to $2.2 billion by 2028.
Amber Therapeutics wasn’t the only women’s health start-up that pulled in a sizeable round in the first half, nor was it the only venture funded company targeting unmet needs for people with urinary incontinence. Women’s health diagnostics company PinkDx, cofounded in 2022 by Veracyte cofounder Bonnie Anderson and based in Daly City, CA, launched in April with a $40 million Series A. The round was led by Catalio Capital Management, LP, and The Production Board, with several other investors participating, including Mountain Group Partners, Byers Capital, and Mayo Clinic.
PinkDx is developing tests aimed at unmet medical needs unique to women, with an initial focus on difficult-to-diagnose gynecological cancers. It aims to “develop solutions to replace invasive and painful diagnostic procedures and mitigate the significant delays women and their doctors often face in obtaining answers.”
In addition, iO Urology, a start-up offering the first digital diagnostic/monitoring platform for home-based urologic care, including incontinence, completed a $19.4 million Series A round in March. iO Urology’s CarePath system consists of an easyto- use, connected hand-held device that patients can use in the privacy of their own home. The device captures data on urine flow rate, volume, time, and duration and a cloud-based analytics platform produces patient reports that the healthcare provider can view on any connected device.
The company’s aim is to improve care for both men and women with lower urinary tract issues, including overactive bladder (urge incontinence), which affects 36% of women and 16% of men in the US, and benign prostatic hyperplasia, which affects 38 million US men, and to provide better tools for clinical trials in the urology/urogynecology area. iO Urology believes CarePath can improve patient compliance, data accuracy, appropriate diagnoses, and patient satisfaction, and decrease healthcare costs.
The Series A round was led by Solas BioVentures and included Launch Tennessee and Jumpstart Capital. It also included two urologic strategics, one of which is Laborie Medical Technologies Corp. (LMT) of Portsmouth, NH, a leading diagnostic and therapeutic medical technology company focused on urology, urogynecology, gastroenterology, OB Gyn, and neonatal health. Based in Knoxville, TN, iO Urology intends to use the proceeds to expand its team and build inventory and distribution capability for CarePath, which is FDA-approved and already in use by urology clinics in the US, according to LMT.
iO Urology also falls into the category of remote patient monitoring (RPM), which surprisingly saw a resurgence in funding in the first half of this year, after a dismal performance in 2023 coming off pandemic- driven highs. And, given RPM’s high growth potential, there’s good reason for that. According to LSI’s Market Intelligence analysts, the global RPM market was valued at $23.7B in 2023 and is projected to reach $40.7B by 2028, a CAGR of 11.4%.
Two other RPM companies that garnered substantial venture rounds in the first half were San Diego-based biosensor developer Allez Health, which closed on a $60 million Series A+ round in May, led by a strategic—Korean in-vitro diagnostics company Osang Healthcare—with participation from existing investors; and LSI alum, San Diego-based Biolinq. Biolinq completed a $58 million Series D round in April, led by Alpha Wave Ventures, with participation from Niterra’s corporate VC fund, jointly operated with Pegasus Tech ventures, and several existing investors, including Taisho Pharmaceutical. Both Allez and Biolinq operate in the diabetes space and are developing next-generation continuous glucose monitoring (CGM) technologies, and both are moving toward regulatory submissions. Biolinq expects to complete a US pivotal trial this year for its wearable patch-based intradermal glucose sensor.
Although CGM devices were originally developed to help people with diabetes, it’s worth noting that the two commercial leaders in the CGM space—Dexcom and Abbott—will soon introduce over-the-counter CGM devices that can be purchased without a prescription, opening up the market to a much wider range of potential users, including health-conscious people without diabetes or prediabetes looking for a wearable to track their metabolic health. The potential upside for the CGM market from OTC sales could be huge and is likely a big consideration for investors interested in next-gen CGM technology.
Later-stage funding (Series B and above) in 2024 has focused largely on precommercial and pivotal trial rounds, and investors now appear to be much more willing to fund technologies with high-growth potential that require large clinical trials (e.g., PMA devices). As a result, recent investments have aided companies targeting a variety of highrisk/ high-reward clinical areas, ranging from cardiovascular to robotics and beyond.
Making the leap from early-stage/Series A funding to Series B has been particularly difficult for medtech companies over the past two years, but this hurdle seems to have eased somewhat over the past six months, with a handful of medical device start-ups recently completing noteworthy Series B rounds.
One of those is cardiovascular company CroiValve, an LSI alum that closed on a $16 million Series B in August. The round was led by MedTech & Irrus Syndicates and included new investor IAG Capital Partners as well as existing investors Ascentifi, Atlantic Bridge University Fund, Broadview Ventures, Elkstone, Enterprise Ireland, Furthr, and SOSV.
Although venture funding for cardiovascular (CV) technologies was down overall in the first half of 2024, according to Jonathan Norris, managing director of HSBC Innovation Banking, CroiValve was able to buck that trend by leveraging its unique technology, designed to address a significant unmet need, and the fact that it already has promising human clinical trial data.
Headquartered in Dublin, Ireland, Croi- Valve is developing a novel transcatheter treatment called DUO for tricuspid heart valve regurgitation (TR) that combines the attributes of valve repair and replacement into one device. DUO consists of a coaptation valve, which fills the valve orifice and works in conjunction with the native valve, along with an anchor system—anchored within the superior vena cava with a stent— that connects to the coaptation valve, locking it in place while allowing normal respiratory and cardiac motion.
According to CroiValve, the system is designed to address the unique challenges inherent in the tricuspid valve, including tissue frailty, the presence of nearby critical structures, and the progressive nature of TR, which causes significant annular dilation and massive regurgitation by the time patients are symptomatic. DUO leaves the frail right heart tissue untouched, so it is safe, the company says. It is also effective for a wide range of anatomies and easy to use, according to CroiValve.
At the New York Valves 2024 conference in June, researchers presented positive sixmonth results from CroiValve’s 10-patient TANDEM I first-in-human study. According to the company, the trial showed that the DUO System could significantly reduce TR, had stable positioning and functionality, and that the procedure was simple and safe, with no incidences of arrhythmia or requirements for permanent pacing. CroiValve is working to bring DUO to the US market and began an FDA IDE feasibility study, TANDEM II, in January.
Another recent Series B comes from Shanghai-based Ronovo Surgical, a surgical robotics company that presented at LSI’s 2023 USA conference. Ronovo closed on a $44 million Series B financing in June, co-led by Guolian Capital and INCE Capital, with participation from King Star Med LP and existing shareholder, LongRiver Investments.
Founded in 2021, Ronovo is developing the Carina Platform, the first modular laparoscopic robotic platform developed in China, but “made for the world,” according to company Founder, Chairman, and CEO, John Ma.
Carina is a flexible and cost-effective robotic surgery platform that allows physicians to choose from multiple docking and set-up configurations. The initial system enables three- and four-arm configurations, with 5mm (straight) and 8mm (articulated) instruments, and it is compatible with Storz or Olympus 3DHD vision systems or with a proprietary Ronovo 3DHD system. Eventually, the company plans to offer more modular configurations, additional diversified instruments, and additional vision capabilities, including integrated preoperative imaging.
The company has more than 100 patent applications and is initially targeting gynecology and urology procedures, with plans to expand to general and thoracic surgery in the future. Its most immediate commercial goal is to increase robotic surgery penetration in the Chinese market, where robotic procedures account for less than 1% of the total minimally invasive surgical volume in the country. Ronovo expects to receive regulatory approval in China and begin commercialization in early 2025. But the company hopes eventually to market the system internationally as well, including in the US, where Ronovo recently launched its first international facility—the Ronovo Institute of Surgical Excellence in Orlando, FL—aimed at “deepening clinical collaboration with top international surgical experts and medical societies.”
A few post-B rounds targeting women’s health and robotics also deserve a closer look.
The largest occurred in February, when robotics company Medical Microinstruments (MMI) closed on a $110 million Series C, which it called “the largest ever investment in microsurgery innovation.” The round was led by Fidelity Management & Research Company and included all of the firm’s existing investors. It follows a $77 million Series B the company raised in 2022, bringing the company’s total funding to date to over $200 million.
Founded in 2015 near Pisa, Italy, with US offices in Jacksonville, FL, MMI intends to use the Series C proceeds to support commercialization of its Symani Surgical System and to invest in additional clinical studies aimed at indication expansion.
Symani, with its NanoWrist instruments, is a first-of-its-kind robotic surgery system designed specifically for microsurgery and supermicrosurgery procedures, replicating the natural movements of the human hand at the micro scale and enabling physicians to safely access and suture vessels as small as 0.3 mm diameter.
The system is CE marked in Europe and received US de novo FDA clearance in April for soft tissue manipulation during microsurgery, making it the only commercially available robotic platform in the US for reconstructive microsurgery, the firm says. The first US clinical cases with the system— for reconstructive extremity microsurgery— were performed in May at Penn Presbyterian Medical Center, and in August, the company performed the first preclinical study of Symani in neurosurgery, demonstrating the feasibility of the system for robotic-assisted microsurgery in an animal brain model.
In June, another company operating in the robotic surgery realm, Oakland, CAbased Promaxo, founded in 2016, garnered $32 million in a Series B3 round, with investment from Zynext Ventures USA, the VC arm of global pharmaceutical company Zydus Lifesciences. In a statement, Jay Kothari, director of Zynext Ventures noted that Promaxo’s “innovative technology aligns perfectly with Zynext’s mission of investing in disruptive new-age healthcare solutions that elevate patient outcomes.”
A presenter at LSI’s USA 2024 conference, Promaxo has developed a portable, low-field MRI system that is open and compact, can be placed in a clinic or operating room, and is designed to be compatible with robotic procedures.
Promaxo’s single-sided MRI with AI based imaging system was the first of its kind in the US to receive FDA 510(k) clearance (in 2021) for use in MR-guided manual and robotic prostate biopsy and targeted therapy. And it has resonated with physicians and patients, with more than 100 sold to date, according to company COO Dinesh Kumar, who told attendees at the LSI conference that Promaxo is “well on the way” to profitability in the next 12-18 months, with a clear path to up to 70% growth margin.
Promaxo is currently working to obtain FDA clearance for its own robot for guided prostate interventions, including targeted and whole gland procedures, and hopes to receive clearance by the end of 2024 or early 2025. It plans to eventually expand to other indications, including female pelvic floor, OB/gyn, kidney, and breast procedures. The company is also expanding into international markets, with EU as the next geography, and has established a subsidiary in Brussels, Belgium.
Another later-stage round of note this year was a $77 million Series C (the last $5 million tranche of which closed in May), that went to women’s health company Meditrina. Meditrina received 510(k) clearance in May for its Gen 2 bipolar RF hysteroscopy system, designed to improve minimally invasive gynecologic procedures by offering faster procedure times, enhanced versatility, and the ability to address difficult-to-treat fibroids. The Series C was led by Deerfield Management Company, ShangBay Capital, and other insiders, and was combined with an additional $5 million debt financing by SLR Capital Partners. Meditrina is “approaching cash-flow positive,” the company said in a statement, and will use the proceeds to accelerate new product introduction and expand its sales force.
Meanwhile, several large Series D medtech rounds also closed this year, including an oversubscribed $102 million round completed in August that went to focused ultrasound company HistoSonics; a $96 million round completed by Nectero Medical, which has a novel drug-device combination technology for stabilizing small abdominal aortic aneurysms (AAAs); and $91 million for knee osteoarthritis device company Moximed (including $61 million up front and an option to close on up to $30 million additional).
HistoSonics plans to use its Series D funds to scale the launch of its noninvasive Edison histotripsy platform, FDA de novo cleared in October 2023, which uses focused ultrasound to destroy and liquefy targeted liver tumors. The company also plans to initiate a clinical study investigating the system for the treatment of liver tumors across multidisciplinary users. The funding round was led by Alpha Wave Ventures, with participation from new investors Amzak Health and HealthQuest Capital, and existing investors Johnson & Johnson Innovation, Lumira Ventures, Yonjin Venture, and others.
Nectero’s $96 million Series D, which closed in April, was led by Norwest Venture Partners, with “large investments” from Boston Scientific Corp., BioStar Capital, Cadence Healthcare Ventures, Aphelion Capital, and others.
The company will use the proceeds to accelerate a Phase II/III trial and support submission of an FDA New Drug Application for its novel Nectero Endovascular Aneurysm Stabilization Treatment (Nectero EAST) System. Nectero EAST uses a single-use dual-balloon catheter to deliver pentagalloyl glucose locally into the aneurysm wall where it binds to elastin and collagen to strengthen the wall and potentially reduce further degradation and growth of the aneurysm. The Phase II/III trial, initiated in January, is investigating Nectero EAST in patients with infrarenal AAAs 3.5-5.5 cm in diameter. There is currently no standard treatment option for people with these smaller AAAs; endovascular treatments are primarily reserved for AAAs larger than 5-5.5 cm, people who are symptomatic, or those with rapidly expanding aneurysms. Smaller aneurysms are typically monitored over time to see if they are enlarging, but they carry a 0.5-5% annual risk of rupture, according to the company, and rupture can be fatal, so there is an unmet need for a safe and effective intervention for these patients. FDA granted Nectero EAST Fast Track and Breakthrough Therapy designations.
Moximed closed its Series D in August and will use the proceeds to accelerate US commercialization of its FDA-cleared MISHA Knee System, the first “implantable shock absorber” for knee osteoarthritis (OA). The MISHA device is implanted during an outpatient procedure and has been shown to alleviate pain, improve function, and delay the need for knee replacement in certain patients with mild-to-moderate OA, the company says. The Series D was led by Elevage Medical Technologies, a platform established by Patient Square Capital. Elevage provides companies in the advanced clinical or commercialization stage with capital as well as technical, regulatory, and operational expertise, and is “dedicated to supporting medical technology companies that can meaningfully improve health outcomes and quality of life for patients.”
Others who participated were new investors Cormorant Asset Management and Warren Point Capital and existing investors New Enterprise Associates, Future Fund, Advent Life Sciences, Gilde Healthcare, Vertex Ventures, GBS Venture Partners, and Morgenthaler.
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