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High technology industry

Smartlens, Inc. Secures $5.2 Million Bridge Round to Advance FDA Clearance and Market Launch for miLens Glaucoma Management Device

Strategic Insights

— 1 min read

Smartlens, Inc., a clinical-stage ophthalmic technology company, has announced the closing of an oversubscribed $5.2 million bridge round led by Ambit Health Ventures. The financing will be used to advance the FDA clearance process and prepare for an expedited market launch following clearance. The round also included continued participation from existing investors Graphene Ventures and Boutique Venture Partners, along with new investment from Harvard Business School Alumni Angels GNY and a group of leading eye care providers. miLens, the world's first electronics-free contact lens technology, is capable of continuous intraocular pressure (IOP) monitoring, working seamlessly with Smartlens' AI-powered smartphone imaging platform. The company plans to initiate commercial activities following FDA clearance, marking a significant milestone in transforming glaucoma care worldwide.

Key Takeaways:

  • Smartlens, Inc. has secured $5.2 million in bridge funding to advance the FDA clearance process for miLens, a revolutionary glaucoma management device.
  • miLens is the world's smallest wearable microfluidic device, designed as an electronics-free soft contact lens for continuous, real-world monitoring of intraocular pressure outside of clinical settings.
  • A survey of 166 ophthalmic practitioners conducted by Market Scope showed exceptionally high interest in miLens, with 96.2% expressing intent to adopt the technology once available.
  • The financing will be used to prepare for an expedited market launch following FDA clearance, with commercial activities set to begin once clearance is obtained.
  • Smartlens has made significant advancements in regulatory preparation, manufacturing scale-up, and clinical validation, with strong clinical progress in its multi-site U.S. pivotal trial.
  • miLens offers unprecedented insight for patients with glaucoma, ocular hypertension, and those requiring post-surgical intraocular pressure monitoring.

Statistics:

  • $5.2 million: The amount of bridge funding secured by Smartlens, Inc. to advance the FDA clearance process for miLens.
  • 96.2%: The percentage of ophthalmic practitioners surveyed by Market Scope who expressed intent to adopt miLens once available.
  • 180 million: The estimated number of people worldwide affected by glaucoma and ocular hypertension.
  • 166: The number of ophthalmic practitioners surveyed by Market Scope.

Sources:

  • Pharma Business Week
  • Smartlens, Inc.
  • Ambit Health Ventures
  • Graphene Ventures
  • Boutique Venture Partners
  • Harvard Business School Alumni Angels GNY

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