Escala Secures $4.5M in Funding to Accelerate Global Expansion of Its FDA-Approved Medical Device
Escala Medical Ltd., a FemTech medical device company specializing in women's health solutions, has secured $4.5 million in funding to accelerate the global expansion of its FDA-approved device for Pelvic Organ Prolapse (POP) treatment.
The funding round includes investment from the EIC Fund, following a €2.5 million grant awarded through the EIC Accelerator program in October 2023, along with participation from private investors in the United States and Israel. The company's flagship Mendit device, which received FDA approval and was commercially launched in 2023, has already been used in hundreds of successful procedures.
The funds will support Escala's commercial operations expansion in the U.S., preparations for European market entry pending CE approval, and international growth through a new distribution agreement covering Southeast Asia. The company currently maintains a direct sales team in the U.S. and is positioned for significant growth in 2025 and beyond.
Escala Medical Ltd., un'azienda FemTech specializzata in dispositivi medici per la salute femminile, ha ottenuto un finanziamento di 4,5 milioni di dollari per accelerare l'espansione globale del suo dispositivo approvato dalla FDA per il trattamento del Prolasso degli Organi Pelvici (POP).
Il round di finanziamento include un investimento da parte dell'EIC Fund, a seguito di una contributo di 2,5 milioni di euro assegnato tramite il programma EIC Accelerator nell'ottobre 2023, insieme alla partecipazione di investitori privati dagli Stati Uniti e da Israele. Il dispositivo di punta dell'azienda, il Mendit, approvato dalla FDA e lanciato commercialmente nel 2023, è già stato utilizzato con successo in centinaia di procedure.
I fondi serviranno a supportare l'espansione delle operazioni commerciali di Escala negli Stati Uniti, la preparazione all'ingresso nel mercato europeo in attesa dell'approvazione CE, e la crescita internazionale attraverso un nuovo accordo di distribuzione per il Sud-est asiatico. Attualmente, l'azienda dispone di un team di vendita diretto negli USA ed è pronta per una crescita significativa nel 2025 e oltre.
Escala Medical Ltd., una compañía FemTech especializada en dispositivos médicos para la salud femenina, ha asegurado 4,5 millones de dólares en financiamiento para acelerar la expansión global de su dispositivo aprobado por la FDA para el tratamiento del Prolapso de Órganos Pélvicos (POP).
La ronda de financiación incluye una inversión del Fondo EIC, tras una subvención de 2,5 millones de euros otorgada a través del programa EIC Accelerator en octubre de 2023, junto con la participación de inversores privados en Estados Unidos e Israel. El dispositivo principal de la empresa, el Mendit, que recibió la aprobación de la FDA y fue lanzado comercialmente en 2023, ya ha sido utilizado con éxito en cientos de procedimientos.
Los fondos apoyarán la expansión de las operaciones comerciales de Escala en EE. UU., los preparativos para la entrada al mercado europeo pendiente de la aprobación CE, y el crecimiento internacional mediante un nuevo acuerdo de distribución que cubre el sudeste asiático. La compañía actualmente cuenta con un equipo de ventas directo en EE. UU. y está posicionada para un crecimiento significativo en 2025 y más allá.
Escala Medical Ltd.는 여성 건강 솔루션을 전문으로 하는 FemTech 의료기기 회사로, FDA 승인 받은 골반 장기 탈출증(POP) 치료기기의 글로벌 확장을 가속화하기 위해 450만 달러의 자금을 확보했습니다.
이번 투자 라운드는 2023년 10월 EIC Accelerator 프로그램을 통해 수여된 250만 유로 보조금에 이어 EIC Fund의 투자와 미국 및 이스라엘의 민간 투자자 참여가 포함되어 있습니다. 회사의 대표 기기인 Mendit는 FDA 승인을 받았으며 2023년에 상업적으로 출시되어 이미 수백 건의 성공적인 시술에 사용되었습니다.
이 자금은 미국 내 Escala의 상업 운영 확장, CE 승인 대기 중인 유럽 시장 진입 준비, 동남아시아를 포함한 국제적 성장 지원을 위한 신규 유통 계약에 사용될 예정입니다. 현재 회사는 미국에 직접 판매팀을 보유하고 있으며 2025년 이후 큰 성장이 기대됩니다.
Escala Medical Ltd., une entreprise FemTech spécialisée dans les dispositifs médicaux pour la santé des femmes, a obtenu un financement de 4,5 millions de dollars pour accélérer l'expansion mondiale de son dispositif approuvé par la FDA pour le traitement du prolapsus des organes pelviens (POP).
Ce tour de financement comprend un investissement du Fonds EIC, suite à une subvention de 2,5 millions d'euros accordée dans le cadre du programme EIC Accelerator en octobre 2023, ainsi que la participation d'investisseurs privés aux États-Unis et en Israël. Le dispositif phare de la société, le Mendit, approuvé par la FDA et commercialisé en 2023, a déjà été utilisé avec succès dans des centaines d'interventions.
Les fonds permettront de soutenir l'expansion des opérations commerciales d'Escala aux États-Unis, les préparatifs pour l'entrée sur le marché européen en attente de l'approbation CE, ainsi que la croissance internationale via un nouvel accord de distribution couvrant l'Asie du Sud-Est. L'entreprise dispose actuellement d'une équipe de vente directe aux États-Unis et est prête pour une croissance significative en 2025 et au-delà.
Escala Medical Ltd., ein FemTech-Medizintechnikunternehmen, das sich auf Gesundheitslösungen für Frauen spezialisiert hat, hat 4,5 Millionen US-Dollar an Finanzierung erhalten, um die globale Expansion seines von der FDA zugelassenen Geräts zur Behandlung des Beckenorganprolaps (POP) zu beschleunigen.
Die Finanzierungsrunde umfasst eine Investition des EIC-Fonds, nachdem im Oktober 2023 ein 2,5 Millionen Euro Zuschuss im Rahmen des EIC Accelerator-Programms vergeben wurde, sowie Beteiligungen von privaten Investoren aus den USA und Israel. Das Flaggschiff-Gerät des Unternehmens, das Mendit, erhielt die FDA-Zulassung und wurde 2023 kommerziell eingeführt; es wurde bereits in Hunderten erfolgreicher Eingriffe eingesetzt.
Die Mittel werden die Expansion der kommerziellen Aktivitäten von Escala in den USA unterstützen, die Vorbereitung des Markteintritts in Europa nach CE-Zulassung sowie das internationale Wachstum durch einen neuen Vertriebsvertrag für Südostasien fördern. Das Unternehmen verfügt derzeit über ein direktes Vertriebsteam in den USA und ist für ein erhebliches Wachstum ab 2025 und darüber hinaus positioniert.
- FDA-approved medical device with hundreds of successful procedures completed
- Secured $4.5 million in funding plus €2.5 million grant from prestigious EIC Accelerator program
- Expanding commercial operations in U.S. with direct sales team
- New distribution agreement secured for Southeast Asian markets
- Pending CE approval for European market entry
- None.
Insights
Escala's $4.5M funding strengthens commercial expansion of its FDA-approved women's health device, signaling growth in the underserved POP treatment market.
Escala Medical's
The company's focus on Pelvic Organ Prolapse (POP) addresses a significant unmet medical need affecting millions of women globally. Their Mendit device, which has already demonstrated clinical utility with hundreds of successful procedures since its 2023 FDA approval and commercial launch, aims to shift treatment from hospital settings to doctor's offices—a potential paradigm shift in care delivery that could substantially reduce healthcare costs while improving accessibility.
The funding allocation strategy is well-balanced: strengthening U.S. commercial operations where regulatory approval is already secured, preparing for European market entry pending CE approval, and expanding into Southeast Asia through a distribution partnership. This three-pronged geographic approach maximizes near-term revenue potential while establishing infrastructure for future growth markets.
The EIC Fund's backing, which is highly selective, provides both financial resources and regulatory credibility that could accelerate institutional adoption and physician acceptance. With a direct sales team already operating in the U.S. and demonstrable clinical performance, Escala has established the foundational elements required for commercial scaling in the women's health market segment—a sector that has historically been underfunded but is gaining increased investor attention due to its significant market potential.
Co-financing by the EIC Fund to ramp up women's health solution to POP
MISGAV,
The funds will be used to expand Escala's commercial operations in the
"This funding marks an important milestone as we continue to scale our operations and bring our breakthrough technology to more women worldwide," stated Dr. Edit Goldberg, CEO of Escala. "We're proud to have the support of the EIB and our private investors, and we remain committed to advancing the next generation of our Mendit device to improve outcomes and expand access to millions of women worldwide who suffer from organ prolapse."
"Being selected for the EIC Accelerator and receiving both a grant and equity investment from the EIC Fund is a major vote of confidence in our technology, our team, and our vision. These programs are among
"The EIC Fund is proud to support visionary companies like Escala. Their work exemplifies the transformative potential we aim to nurture through the EIC. This marks a significant milestone in their journey to bring much-needed innovation to women's health," said Svetoslava Georgieva, Chair of the EIC Fund Board.
Escala currently has a direct sales team of representatives operating in the
About Escala Medical
Escala, a FemTech medical device company, is a portfolio company of The Trendlines Group Ltd. (SGX: 42T) (OTCQX: TRNLY). Escala is committed to offering its groundbreaking repair alternative for women at all stages of pelvic organ prolapse. By shifting the point of care from the hospital to the doctor's office, Escala is committed to transforming the treatment paradigm for pelvic organ prolapse worldwide.
About EIC Fund
The European Innovation Council Fund from the European Commission is an agnostic Fund: it invests across all technologies and verticals, and all EU countries and countries associated to Horizon Europe. It provides the investment component of the EIC Accelerator blended finance. The European Investment Bank acts as investment adviser to the EIC Fund.
The EIC Fund aims to fill a critical financing gap and its main purpose is to support companies in the development and commercialisation of disruptive technologies, bridging with and crowding in market players, and further sharing risk by building a large network of capital providers and strategic partners suitable for co-investments and follow-on funding.
The Fund pays particular attention to the empowerment and support of female founders as well as the ambition to reduce the innovation divide among EU countries.
Photo: https://mma.prnewswire.com/media/2721711/Escala_Medical_Ltd.jpg
Media Contact:
Edit Goldberg
CEO, Escala Medical
edit@escalamedical.com
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SOURCE Escala Medical Ltd.
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