Latest news with #Carlsmed
Yahoo
a day ago
- Business
- Yahoo
Carlsmed seeks up to $103M IPO haul to fuel spine surgery growth
This story was originally published on MedTech Dive. To receive daily news and insights, subscribe to our free daily MedTech Dive newsletter. Dive Brief: Carlsmed has set the target range for its initial public offering, outlining plans to raise up to $103.3 million to support development and commercialization of its spine surgery platform. Carlsmed plans to offer 6.7 million shares of common stock at an expected range of $14 to $16 per share, as well as an underwriters' option to purchase more than 1 million shares. The company, which set the price range Tuesday, sells artificial intelligence-enabled software, custom implants and single-use instruments for spine surgeries. Cross-trial comparisons suggest the custom devices may improve alignment and reduce revisions compared to stock implants. Carlsmed's products compete with stock spine implants sold by companies including Medtronic, Johnson & Johnson and Globus Medical. The company is much smaller than its rivals but growing quickly, with sales increasing by almost 100% in 2024 and on track to rise again this year. Dive Insight: Carlsmed is developing its platform to address the limitations of traditional spine fusion procedures. The company has identified the lack of sufficient pre-operative planning, the fit of stock interbody implants and complicated surgical workflows as problems. Targeting a $13.4 billion addressable market, Carlsmed is working to address these issues to improve patient outcomes and cut healthcare costs. The resulting platform uses diagnostic imaging and AI-enabled algorithms to develop personalized digital surgical plans and design custom interbody implants for each patient. Carlsmed collects real-world, post-operative data to improve the planning process. Researchers have generated evidence of the effectiveness of the platform, including through a registry that is tracking real-world clinical outcomes. An interim analysis of 67 adult spinal deformity patients in the registry found the rate of revision surgery attributable to mechanical complications was 1.5% after a mean follow-up of 14.7 months, according to a federal securities filing. The one-year revision rate in another study of stock implants was 8.7%. Carlsmed reported revenue of $27.2 million last year, up almost 100% compared to 2023, and is on track to grow again in 2025. The company generated sales of around $22.2 million over the first half of 2025. Carlsmed plans to keep growing by adding users and increasing use by existing customers. The number of surgeons who have used the platform increased from 103 as of March 2024 to 199 as of June 2025. Carlsmed's IPO paperwork reveals some of the challenges the company is facing as it scales operations. The company's net loss increased last year, rising to $24.2 million, and its reliance on a limited number of contract manufacturing organizations has hurt margins. Delays in the approval of surgical plans or late changes in surgery dates can cause CMOs to charge expedite fees. The fees drove margins down in the second quarter. Carlsmed expects expedite fees to decrease over time as it tries to improve operational processes and procedural workflows used by surgeons. Carlsmed's filing to list on Nasdaq adds to the uptick in medtech IPO activity seen this year. IPO filings are still well down from the pandemic-era peak but, after years of limited activity, some analysts believe a backlog of companies is waiting for favorable conditions to list. The success or failure of companies such as Carlsmed could inform whether the IPO window opens or closes. Recommended Reading The medtech IPO window is finally open. Or is it? Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Axios
5 days ago
- Business
- Axios
DOGE makes its way into biotech IPO filings
DOGE cuts are leading to new warnings in filings from biotech and health-care companies looking to IPO stateside. The big picture: Uncertainty is a deal killer. According to data from Renaissance Capital, there have been just four biotech IPOs this year that have raised over $50 million — down from 10 in the same period last year. Venture bets are slowing too. Driving the news: Carlsmed, a personalized spine surgery company backed by B Capital Group and U.S. Venture Partners warned in its prospectus that "the current U.S. presidential administration" has issued policies to cut headcount and budgets in agencies including the FDA. "It remains unclear the degree to which these efforts may limit or otherwise adversely affect the FDA's ability to conduct routine activities," it continued. Sixth Street-backed cancer diagnostics company, Caris Life Sciences, which went public in late June, said this: "The current Trump administration is pursuing policies to reduce regulations and expenditures across government including at HHS, the FDA, CMS, and related agencies," Caris' prospectus read. "These actions ... may propose policy changes that create additional uncertainty for our business. Zoom out: Though Carlsmed says it's "unclear the degree to which" the cuts will affect the FDA's ability to conduct routine activity, those in the space already feel the effects. The FDA told KalVista Pharmaceuticals last month that the agency would miss a deadline in approving a drug for potentially life-threatening genetic disorders — marking what appears to be the first time a review had to be extended over DOGE cuts. Verve Therapeutics, in a filing explaining its rationale for selling to Eli Lilly for $1.3 billion, noted that Peter Marks resignation in March as director of the FDA played a role in its move to sell rather than raise additional capital.
Bloomberg
5 days ago
- Business
- Bloomberg
AI-Surgical Firm Carlsmed Seeks to Raise $107.2 Million in IPO
Carlsmed Inc., a medical technology company that uses AI to personalize spine surgery, is seeking to raise as much as $107.2 million in a US initial public offering. The B Capital Group -backed firm plans to market 6.7 million shares for $14 to $16 each, according to its Tuesday filing with the US Securities and Exchange Commission.
Yahoo
5 days ago
- Business
- Yahoo
Carlsmed Announces Launch of Initial Public Offering
CARLSBAD, Calif., July 15, 2025--(BUSINESS WIRE)--Carlsmed, Inc. ("Carlsmed"), a commercial-stage medical technology company pioneering AI-enabled personalized spine surgery solutions, today announced the launch of its initial public offering of 6,700,000 shares of common stock. In addition, the underwriters will have a 30-day option to purchase up to 1,005,000 additional shares of common stock from Carlsmed at the initial public offering price, less underwriting discounts and commissions. The initial public offering price is expected to be between $14.00 and $16.00 per share of common stock. Carlsmed has applied to list its common stock on the Nasdaq Global Select Market under the ticker symbol "CARL." BofA Securities, Goldman Sachs & Co. LLC, and Piper Sandler are acting as joint lead book-running managers for the proposed offering. Truist Securities and BTIG are acting as joint book-runners for the proposed offering. The proposed offering will be made only by means of a prospectus. A copy of the preliminary prospectus, when available, may be obtained from: BofA Securities, NC1-022-02-25, 201 North Tryon Street, Charlotte, North Carolina 28255-0001, Attention: Prospectus Department, or by email at Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, New York 10282, by email at prospectus-ny@ or by phone number at (866) 471-2526; or Piper Sandler & Co., Attention: Prospectus Department, 350 North 5th Street, Suite 1300, Minneapolis, Minnesota 55402, by email at prospectus@ or by telephone at (800) 747-3924. A registration statement on Form S-1 relating to these securities has been filed with the U.S. Securities and Exchange Commission but has not yet become effective. These securities may not be sold, nor may offers to buy be accepted, prior to the time the registration statement becomes effective. This press release shall not constitute an offer to sell or the solicitation of an offer to buy any securities, 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 or jurisdiction. About Carlsmed Carlsmed is a commercial-stage medical technology company pioneering AI-enabled personalized spine surgery solutions with a mission to improve outcomes and decrease the cost of healthcare for spine surgery and beyond. We are focused on becoming the standard of care for spine fusion surgery. View source version on Contacts Investor Relations Caroline Corner, PhDPartner ICR HealthcareIR@ Media Inquiries LeAnn BurtonSenior Director Brand MarketingLBurton@ Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Business Wire
5 days ago
- Business
- Business Wire
Carlsmed Announces Launch of Initial Public Offering
CARLSBAD, Calif.--(BUSINESS WIRE)--Carlsmed, Inc. ('Carlsmed'), a commercial-stage medical technology company pioneering AI-enabled personalized spine surgery solutions, today announced the launch of its initial public offering of 6,700,000 shares of common stock. In addition, the underwriters will have a 30-day option to purchase up to 1,005,000 additional shares of common stock from Carlsmed at the initial public offering price, less underwriting discounts and commissions. The initial public offering price is expected to be between $14.00 and $16.00 per share of common stock. Carlsmed has applied to list its common stock on the Nasdaq Global Select Market under the ticker symbol 'CARL.' BofA Securities, Goldman Sachs & Co. LLC, and Piper Sandler are acting as joint lead book-running managers for the proposed offering. Truist Securities and BTIG are acting as joint book-runners for the proposed offering. The proposed offering will be made only by means of a prospectus. A copy of the preliminary prospectus, when available, may be obtained from: BofA Securities, NC1-022-02-25, 201 North Tryon Street, Charlotte, North Carolina 28255-0001, Attention: Prospectus Department, or by email at Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, New York 10282, by email at prospectus-ny@ or by phone number at (866) 471-2526; or Piper Sandler & Co., Attention: Prospectus Department, 350 North 5th Street, Suite 1300, Minneapolis, Minnesota 55402, by email at prospectus@ or by telephone at (800) 747-3924. A registration statement on Form S-1 relating to these securities has been filed with the U.S. Securities and Exchange Commission but has not yet become effective. These securities may not be sold, nor may offers to buy be accepted, prior to the time the registration statement becomes effective. This press release shall not constitute an offer to sell or the solicitation of an offer to buy any securities, 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 or jurisdiction. About Carlsmed Carlsmed is a commercial-stage medical technology company pioneering AI-enabled personalized spine surgery solutions with a mission to improve outcomes and decrease the cost of healthcare for spine surgery and beyond. We are focused on becoming the standard of care for spine fusion surgery.
