ROSE Diagnostics

ROSE Diagnostics

Open  for investment

About this raise: ROSE Diagnostics, with a valuation of $15 million, is raising funds on StartEngine. The company is revolutionizing cancer biopsies with point-of-care solutions that provide biopsy sample verification in five minutes. ROSE Diagnostics aims to reduce cancer patients’ stress, time to diagnosis, and cost by providing pathology review at the place and time of cancer biopsy procedures. The company has developed the product, run over 3,000 lab tests, and had a positive FDA pre-submission, and is set for clinical study in Q1 2025 with FDA submission planned for Q3 2025. Andrew Morris, Eric Brouwer, Donna Padavan, and Adolfo Velasquez founded ROSE Diagnostics in July 2023. The current crowdfunding campaign has a minimum target of $123,983.16 and a maximum target of $1.23 million. The campaign proceeds will be used for product development, company management, pre-clinical studies, clinical studies, and other corporate overheads.

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Investment Overview

Committed this round: $81,100

Deal Terms

Total Commitments ($USD)

Platform
StartEngine
Start Date
11/18/2024
Close Date
02/13/2025
Min. Goal
$123,983
Max. Goal
$1,234,986
Min. Investment

$490

Security Type

Equity - Common

Series

Series A

SEC Filing Type

RegCF    Open SEC Filing

Price Per Share

$28.84

Pre-Money Valuation

$14,998,357

Company & Team

Company

Year Founded
2023
Industry
Healthcare & Pharmaceuticals
Tech Sector
HealthTech
Distribution Model
B2B2C
Margin
Medium
Capital Intensity
High
Location
Carlsbad, California
Business Type
Growth
Company Website
Visit Website

Team

Employees
5
Prior Founder Exits?
No
Founder Name
Andrew Morris
Title
Board Member, Chief Executive Officer, Principal Accounting Officer
Founder Name
Adolfo Velazquez
Title
Board Member and Chief Technical Officer
Founder Name
Eric Brouwer
Title
Board Member, Chief Scientific Officer
Founder Name
Donna Padavan
Title
Board Member and VP of Clinical & Regulatory Affairs

Financials

as of November 1, 2024
 Revenue
$0
 Monthly Burn
$62,000
 Runway
10 months

Summary Profit and Loss Statement

FY 2023 FY 2022

Revenue

$0

$0

COGS

$0

$0

Tax

$0

$0

 

 

Net Income

$-63,761

$0

Summary Balance Sheet

FY 2023 FY 2022

Cash

$5,792

$0

Accounts Receivable

$0

$0

Total Assets

$5,792

$0

Short-Term Debt

$0

$0

Long-Term Debt

$0

$0

Total Liabilities

$0

$0

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Synopsis

ROSE Diagnostics is a healthcare company focused on enhancing the efficiency and accuracy of cancer biopsies. It aims to address the challenges faced during cancer diagnosis by providing point-of-care solutions. The company's primary customers include healthcare providers, such as hospitals and clinics, involved in conducting cancer biopsies and pathology reviews.

The problem ROSE Diagnostics addresses is the stress and uncertainty associated with cancer biopsies. Traditional biopsy processes can be time-consuming and costly, often requiring patients to wait days or weeks for pathology results. This delay can increase anxiety and complicate treatment planning.

ROSE Diagnostics offers a solution through its point-of-care technology, which verifies biopsy samples within five minutes. This rapid verification process allows for immediate pathology review at the time and place of the biopsy procedure. By ensuring the correct tissue is biopsied and analyzed promptly, ROSE Diagnostics helps streamline the diagnostic process.

For many people, waiting for biopsy results can be a stressful experience, filled with anxiety and uncertainty. Imagine having a procedure done and then waiting days or even weeks to learn the outcome. ROSE Diagnostics' solution aims to reduce this waiting period significantly. By providing near-instantaneous feedback, it allows patients and healthcare providers to make faster and more informed decisions, potentially reducing the overall stress and inconvenience associated with cancer diagnosis.

Next Section: Price

Price

ROSE Diagnostics is offering common equity in its current fundraising round. The company's pre-money valuation is set at approximately $15 million, with shares priced at $28.84 each. Common equity provides investors with voting rights and potential dividends, but it typically lacks the liquidation preferences and other protections associated with preferred equity.

For startups like ROSE Diagnostics, achieving a 10X return for investors generally requires significant growth in valuation. This could occur through successful FDA approval, market penetration, and revenue generation. The company would need to reach a valuation of at least $150 million to provide such returns, not accounting for potential dilution.

Next Section: Market

Market

The U.S. cancer diagnostics market, valued at approximately $34.2 billion, is experiencing a steady growth rate of 6.16%. Key drivers in this market include the rising incidence of cancer, advancements in diagnostic technologies, and the increasing demand for early and accurate diagnosis. These factors are pushing healthcare providers to adopt more efficient diagnostic solutions, which can be beneficial for ROSE Diagnostics as it positions its point-of-care technology.

Market trends show a shift towards personalized medicine and precision diagnostics, emphasizing the need for rapid and reliable diagnostic tools. The trend towards integrating diagnostic processes within point-of-care settings is particularly relevant to ROSE Diagnostics' offering, potentially enhancing its acceptance and use among healthcare providers. However, the market is also subject to stringent regulatory requirements, which could impact the speed of adoption and the company's growth trajectory.

While the market is extensive, ROSE Diagnostics targets a specific niche within it—cancer biopsy sample verification. This focus on a particular segment allows the company to address specific pain points, such as the time and stress associated with traditional biopsy procedures. By providing rapid sample verification, ROSE Diagnostics can appeal to healthcare facilities looking to improve patient experience and streamline diagnostic workflows.

Next Section: Team

Team

ROSE Diagnostics is led by a team with diverse expertise in healthcare, technology, and regulatory affairs. Andrew Morris serves as the CEO and brings over 21 years of industry experience. His leadership and managerial skills are crucial for steering the company through its developmental and regulatory phases. Adolfo Velazquez, the Chief Technical Officer, has 13 years of experience and plays a pivotal role in overseeing the technical aspects of product development.

Eric Brouwer, the Chief Scientific Officer, contributes 24 years of industry experience, providing scientific oversight and ensuring the company's solutions meet high-quality standards. Donna Padavan, as the VP of Clinical & Regulatory Affairs, has a decade of experience navigating the complex regulatory landscape, which is vital for the company's FDA approval process.

The team's collective expertise aligns well with ROSE Diagnostics' goals of advancing its product through clinical trials and achieving market entry. However, the company may benefit from additional expertise in scaling operations and commercial strategy as it progresses towards market launch. Addressing these areas could be critical for achieving future milestones and expanding market presence.

Next Section: Differentiation

Differentiation

ROSE Diagnostics operates within a competitive landscape that includes companies like Exact Sciences and Guardant Health. These competitors are larger and more established, with a broader range of diagnostic products and services. Exact Sciences focuses on early cancer detection and prevention, offering tests like Cologuard for colorectal cancer screening. Guardant Health specializes in blood-based tests for cancer detection and treatment monitoring. Both companies have significant market presence and resources.

ROSE Diagnostics differentiates itself by offering point-of-care biopsy sample verification, a niche that addresses specific needs in the diagnostic process. This focus on real-time verification at the biopsy site sets it apart from competitors who may not offer such immediate solutions. While Exact Sciences and Guardant Health provide comprehensive diagnostic services, ROSE Diagnostics targets a particular pain point in the biopsy process, which can be a key differentiator.

Next Section: Performance

Performance

ROSE Diagnostics is currently in the early stages of development, with no revenue generated to date. The company has focused on product development and regulatory progress, having completed over 3,000 lab tests and received positive feedback from an FDA pre-submission. These steps are critical for advancing towards clinical studies and eventual market entry.

Financially, the company reported a most recent cash on hand of $620k, with a monthly burn rate of $62k. This burn rate indicates that the company has approximately ten months of runway before requiring additional funding, assuming no changes in expenses or revenue generation.

ROSE Diagnostics' assets are minimal, with total assets at the end of the most recent fiscal year reported at $5,792. The company has no recorded revenue or liabilities, highlighting its current focus on development and regulatory milestones rather than commercial operations.

Next Section: Risk

Risk

ROSE Diagnostics faces several specific risks that investors should consider. The company is currently in a pre-product phase, with no revenue yet generated. This stage inherently involves risks related to product development and market entry. Successfully advancing to clinical studies and achieving FDA approval are critical milestones that carry their own uncertainties.

Regulatory hurdles are significant in the healthcare industry, particularly for a company focused on cancer diagnostics. ROSE Diagnostics must navigate stringent FDA regulations and approval processes, which can be time-consuming and costly. Any delays or setbacks in this process could impact the company's timeline and financial projections.

Adoption risk is also present, as the company introduces a novel point-of-care solution into an established market. Gaining acceptance among healthcare providers and integrating the product into existing workflows will be essential for market penetration. Additionally, ROSE Diagnostics operates with a high capital intensity level, requiring substantial investment for product development and regulatory compliance. The company's monthly burn rate of $62k could deplete cash reserves without additional funding, potentially affecting its runway and operational capacity.

Next Section: Bullish Outlook

Bullish Outlook

The bullish outlook for ROSE Diagnostics is supported by several positive factors that highlight its potential for success. The U.S. cancer diagnostics market, valued at $34.2 billion and growing at 6.16%, presents a significant market opportunity. ROSE Diagnostics' focus on rapid biopsy verification provides a unique competitive advantage, addressing specific inefficiencies in traditional diagnostic processes.

Growth drivers include the increasing demand for point-of-care diagnostic solutions, which align with trends towards personalized and efficient healthcare services. ROSE Diagnostics' technology leverages these trends, potentially enhancing its adoption among healthcare providers. As the company progresses towards clinical studies and regulatory approval, these growth drivers could pave the way for expanded market presence and revenue generation.

While the company has yet to generate revenue, its development progress is notable, with over 3,000 lab tests completed and positive feedback from an FDA pre-submission. These achievements indicate a strong foundation for eventual commercialization. As the company advances, securing additional funding could further bolster its financial health, providing the necessary resources to achieve product development and market expansion goals.

Next Section: Bearish Outlook

Bearish Outlook

The bearish outlook for ROSE Diagnostics stems from several key factors that could impede its growth and market success. The company faces significant regulatory hurdles, particularly in obtaining FDA approval for its point-of-care diagnostic solution. Navigating these complex processes can be both time-consuming and costly, potentially delaying market entry and impacting its financial projections.

Financially, ROSE Diagnostics is in a precarious position with no revenue generated and a monthly burn rate of $62k. This high burn rate, coupled with $620k in cash, suggests a limited runway, highlighting the need for additional funding to sustain operations until it achieves revenue generation. The current valuation of $15 million could be considered high for a pre-product company, potentially deterring investment from those seeking more favorable terms.

Next Section: Executive Summary

Executive Summary

ROSE Diagnostics is a healthcare company focused on enhancing cancer biopsy procedures through point-of-care solutions. Its core customers are healthcare providers, including hospitals and clinics, seeking to improve diagnostic efficiency and patient experience.

The company is offering common equity, with a pre-money valuation of approximately $15 million and a share price of $28.84. ROSE Diagnostics is in the pre-product phase, with no revenue yet, and a monthly burn rate of $62k. The company holds $620k in cash, providing a limited runway for operations. Key financial metrics reflect its early-stage status, emphasizing the need for successful product development and market entry.

The U.S. cancer diagnostics market, valued at $34.2 billion and growing at 6.16%, presents opportunities for ROSE Diagnostics. The company's niche focus on rapid biopsy sample verification differentiates it from larger competitors like Exact Sciences and Guardant Health. Its solution targets a specific pain point, potentially appealing to a defined segment of healthcare providers.

From a bullish perspective, ROSE Diagnostics benefits from favorable market trends and a differentiated product offering that addresses specific diagnostic challenges. Its focus on reducing biopsy turnaround times could enhance its appeal to healthcare providers. Conversely, the bearish outlook highlights the company's pre-revenue status, regulatory challenges, and limited financial runway as potential growth inhibitors.

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Company Funding & Growth

Funding history

Total Prior Capital Raised
$1,077,464
VC Backed?
No
Close Date Platform Valuation Total Raised Security Type Status Reg Type
02/13/2025 StartEngine $14,998,357 $81,100 Equity - Common Active RegCF
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ROSE Diagnostics on StartEngine 2024
Platform: StartEngine
Security Type: Equity - Common
Valuation: $14,998,357
Price per Share: $28.84

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