Reshape Lifesciences Inc. is a physician-led company specializing in weight-loss and metabolic health solutions, focusing on innovative devices like the Lap-Band systems and other bariatric technologies.

# Company Overview: Reshape Lifesciences Inc.

## Business Focus:
- Reshape Lifesciences Inc. (ReShape) is a physician-led company specializing in weight-loss solutions and metabolic health management.
- The company offers an integrated portfolio of products and services aimed at managing and treating obesity and related metabolic diseases throughout the entire care continuum.

## Core Products:
- **Lap-Band System**: An FDA-approved, minimally invasive adjustable gastric band designed for long-term treatment of severe obesity. It is an alternative to more invasive surgeries like gastric bypass or sleeve gastrectomy.
- **Lap-Band 2.0 FLEX System**: A recent FDA-approved upgrade to the original Lap-Band, featuring adjustable pressure post-operation and a new band reservoir technology to relax the band temporarily, potentially increasing efficacy and patient comfort.
- **ReShape Obalon Balloon System**: The first and only swallowable, gas-filled FDA-approved balloon, introduced with an OEM partnership. The relaunch is anticipated in late 2025 for distribution in the U.S. and globally.
- **ReShape Calibration Tubes**: Multifunctional devices to aid bariatric procedures, approved by the FDA in 2022.
- **DBSN Device**: An under-development neuromodulation device aimed at reducing dependence on medications for Type 2 diabetes, utilizing bioelectronics to manage blood glucose through vagus nerve modulation.

## Recent Developments:
- Entered exclusive distribution agreement in Canada for Lap-Band 2.0 FLEX (Feb 2025).
- Raised capital through a securities purchase agreement with warrants and shares (Feb 2025).
- Secured a key international patent from Israel for Diabetes Neuromodulation technology (Feb 2025).
- Planning a merger with Vyome Therapeutics to focus on immune-inflammatory assets (announced Jan 2025).
- Filed multiple SEC registration statements related to these mergers and asset sales.

## Market & Industry:
- The global obesity epidemic affects over 2.5 billion adults, with a projected increase to 50% of the world population by 2030.
- Obesity costs the global economy approximately $2.0 trillion and increases healthcare costs substantially.
- The U.S. obesity market includes an estimated 160 million overweight or obese adults, with high rates of comorbidities such as Type 2 diabetes and hypertension.
- The surgical device market for obesity is projected to reach $2.8 billion worldwide by 2025.
- The weight-loss industry is projected to grow to $300 billion globally by 2026.

## Financial & Employee Information:
- As of December 31, 2024:
  - **Employees**: 18 total (17 full-time, 1 part-time), all based in the U.S.
  - **Cash, cash equivalents, restricted cash**: approximately **$0.8 million**.
  - **Accounts receivable**: approximately **$1.0 million**.
  - No significant revenue was recorded in 2024, with ongoing development and commercialization.
- The company is not currently profitable and relies on external financing, recent capital raises, and strategic transactions for funding.

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*Note:* The company is in development, regulatory approval, and commercialization phases, with no reported revenue or income for 2024.

ReShape Lifesciences Inc. is a global medical device company focused on providing innovative weight-loss solutions through the development of advanced medical devices for managing obesity and related diseases.

# ReShape Lifesciences Inc. Summary

## Overview
ReShape Lifesciences Inc. is a global medical device company focused on providing comprehensive weight-loss solutions. The company specializes in the development, commercialization, and sale of innovative medical devices aimed at managing and treating obesity and related metabolic diseases.

### Key Products
1. **Lap-Band® System**: 
   - An FDA-approved adjustable gastric banding system designed for long-term weight loss through minimally invasive surgical procedures.
   - Positioned as an alternative to more invasive surgeries like gastric bypass and sleeve gastrectomy.

2. **Lap-Band 2.0 FLEX System**:
   - An enhanced version of the Lap-Band with improved features and FDA approval received in December 2023, with first surgeries conducted in early 2024.

3. **Obalon Balloon System**:
   - The first swallowable, gas-filled balloon system for weight loss, which is expected to be reintroduced in the U.S. market in late 2024.

4. **DBSN Device**:
   - Under development; aims to manage type 2 diabetes via bioelectronic technology.

### Business Strategy
The company has established three pillars for growth:
- **Disciplined Operations**: Targeting revenue growth and profitability with a focused cost-reduction plan.
- **Product Portfolio Expansion**: Commitment to driving new product development through internal efforts and strategic partnerships.
- **Clinical Evidence and Collaboration**: Developing an evidence-based portfolio while partnering with healthcare professionals for validation and market adoption. 

### Financials
- **Employees**: 31 (29 full-time and 2 part-time)
- **Revenue**: $8.67 million for the fiscal year ended December 31, 2023 (a decrease from $11.24 million in 2022).
- **Net Loss**: Approximately $11.39 million for the fiscal year ended December 31, 2023, compared to a net loss of $46.21 million for the previous year.
- **Market Capitalization**: As of June 30, 2023, the aggregate market value of the common stock held by non-affiliates was approximately $5 million.

### Market Presence
- The company operates primarily in the **United States**, **Australia**, and select countries in **Europe** and the **Middle East**.
- Total customers served have not been disclosed, but the company emphasizes working with qualified surgical centers and healthcare professionals to execute weight loss treatments using their products.

### Challenges and Outlook
- The introduction of GLP-1 pharmaceuticals has created significant competition in the market for obesity treatments, impacting revenue and unit sales of the Lap-Band system.
- Management is focused on strategic growth initiatives, including the reintroduction of the Obalon system and improvements to the Lap-Band series, while navigating operational constraints and financial performance pressures. 

### Regulatory Environment
- The company's products are subject to rigorous regulations by the FDA and similar authorities to ensure safety and efficacy.

### Research and Development
- Continuous investment in innovation is crucial to the company’s strategy, highlighting a commitment to enhancing existing products and developing new technologies to address obesity and metabolic diseases effectively. 

In conclusion, ReShape Lifesciences is positioning itself as a leader in the obesity treatment arena through innovative products, strategic business practices, and ongoing development efforts, despite facing industry pressures and competition.

ReShape Lifesciences Inc.

10-K / April 4, 2025

10-K / April 1, 2024

10-K / April 4, 2025

Company Overview: Reshape Lifesciences Inc.

Business Focus:

Core Products:

Recent Developments:

Market & Industry:

Financial & Employee Information: