Renowned Brain Surgeons Validate LuminusMicro Devices; New Manufacturing Breakthroughs Reduce Production Costs While Global Medtech Firms Compete for Lead Investor Positions

Q3 2024

Two of the foremost brain surgeons in the U.S. independently met with LuminusMicro CEO Russ Meek to experience our cutting-edge technology firsthand. Each was astounded by our devices’ unparalleled HD image quality, intuitive surgical navigation, and their ability to deliver precisely targeted treatments at an unprecedented “micro-scale.”

Both surgeons confirmed that LuminusMicro devices are not only a fraction of the size but also a fraction of the cost of the most advanced devices on the market today. They each identified groundbreaking procedural opportunities for LuminusMicro within neurosurgery and multiple surgical fields, including our initial target market—ENT surgery. For more information, please contact management.

Manufacturing Breakthroughs

Recognizing the immense market potential and robust patent portfolio of LuminusMicro, leading global manufacturing firms have initiated in-person visits with our engineers and management. They are presenting their most innovative designs and competitive pricing for key components, vying to be integrated into LuminusMicro products.

Additionally, a top-tier medical device illumination company developed a custom solution that simplifies the installation of LuminusMicro’s illumination subsystem and significantly reduces production costs. This development marks a monumental breakthrough for LuminusMicro in terms of profitability and scalability, solidifying a strategic alliance with another leading global producer.

Global Medtech Firms Compete for Lead Investor Positions

In recent weeks, four leading medtech firms have completed extensive due diligence on LuminusMicro as part of their consideration for strategic partnerships. Fully convinced of our potential, they have each entered negotiations for direct investments to expedite the LuminusMicro launch.

One of these firms is an East Coast medical device venture capital group, bringing executive talent and industry connections that will further bolster our accomplished team. The other three are premier medical manufacturers that have historically ceased investing in new medical technologies, let alone offering production space.

This level of industry validation is unparalleled. We are carefully evaluating the benefits of these potential investments as an adjunct to private funding sources, which could allow us to engage these firms as independent contractors. This approach would maintain our flexibility to collaborate with multiple firms and facilities, supporting the high demand for LuminusMicro devices, expanding our application portfolio across all surgical markets, and forming strategic partnerships to maximize shareholder returns.

Leading Medical Manufacturers Pursue Collaboration with LuminusMicro and Propel Orthopedic Innovations

Q4 2021

Over the past few years, we’ve continued to receive resounding confirmation from leading medical manufacturers and device companies: they simply lack the expertise to replicate or produce LuminusMicro devices.

This validation of our patented designs has translated into tangible commitments and bids from top North American manufacturers. They’re eager to scale up US manufacturing, navigate regulatory compliance, and drive disruptive sales in the market.

During the rigorous engineering and testing phase, we achieved significant breakthroughs in design, leading to the creation of two new families of patent applications filed globally in January of this year. These assets are game-changers because:

• They drastically simplify manufacturing processes, reducing complexity and costs.
• They enhance the durability of our near-microscopic internal components.
• They pave the way for future generations of devices to be even smaller in diameter.

In addition, recent meetings with emerging therapeutic companies in the orthopedic sector have uncovered exciting collaborative opportunities. We’ve identified high-impact avenues that significantly enhance the future launch for our subsidiary, LuminusOrtho.

LuminusMicro devices, with their unique navigation and targeting capabilities at the “micro” scale, serve as the ideal delivery vehicles for various regenerative agents, new therapeutic lasers, micro-surgical probes, and other precise tools. Each of these modalities not only presents new revenue streams for surgeons but also acts as a major catalyst in reducing or even eliminating pain and surgical trauma.

Luminus Micro Now Poised to Launch Groundbreaking Microsurgical Devices, Garnering Favorable Industry Attention

Q2 2024

After years of innovative engineering, patents and market development, LuminusMicro is now prepared to launch a series of powerful new microsurgical devices. LuminusMicro devices are proven to give surgeons access to key anatomy never seen outside of an operating room, where they achieve unmatched diagnostic accuracy and are also able to deliver treatments with new safety, speed and precision.

Meeting the highest standard for contamination and infection risks, LuminusMicro devices are 100% sterile (disposable – never needing to be cleaned for reuse on another patient). The operating system is portable and nearly free to adopt, offering immediate benefits for all participants in healthcare. Many top surgeons agree that Luminus devices are equipped to bring today’s minimally invasive surgeries into the next era of micro-procedures.

BUSINESS STRATEGY

Considering the micro-size and new capabilities that LuminusMicro devices offer, our surgeon advisors have identified a series of high-volume, high-impact procedure opportunities in every surgical market. Management plans to build a microsurgical brand to deliver breakthroughs into each space, with keen focus on ENT and the Ortho-Spine spaces. Overall, the Luminus business opportunity exceeds a billion US dollars in each surgical market (the long-term portfolio includes 12 potential microsurgical device brands).

TEAM & ASSETS

The Luminus executive team brings together an impressive list of successes where they helped to create and commercialize market-changing, global products that each generated over a $1Billion in sales. Examples include Apple Computers, 3D printing, Arthroscopic Surgery, and several pharmaceutical products. To carry out training and sales, a national distribution network also stands ready.

NEXT STEPS

With Luminus Gen-1 (“X1”) products refined for volume production, management received favorable bids from (5) top US manufacturers to scale up production and complete FDA clearance. Recent reports confirm that Luminus devices are Class II endoscopes – the fastest devices at gaining FDA clearance – often in less than 35 days once production, case impacts and training protocols are documented.

NEW CAPITAL / LIMITED SHAREHOLDER OPPORTUNITY

Multiple healthcare securities firms have agreed on favorable terms and budgets to capitalize the first Luminus product launch. This budget completes key milestones including the 510(k) certification, extinguishing debt, and engaging first live human case use with advising surgeons in key regions. From there sales, operations and engineering staff will expand to support a national sales expansion.

Factors in the firm’s decision to engage Luminus Holdings included the following achievements of management, despite pandemic-related challenges:

● Advancing engineering/pre-production to the manufacture stage
● Validation of demand for the products and straightforward FDA paths
● Expansion of the executive and sales teams, and intellectual property assets
● Expansion of financial resources who intend to invest at specific milestones

Multiple Engineering Breakthroughs Move LuminusMicro towards Rapid FDA Clearance and Market Expansion

Q3 2022

Our engineering team’s continuous innovations have led to significant breakthroughs and extensive new patent opportunities. These breakthroughs are not just incremental improvements; they represent a quantum leap forward in our device designs.

Remarkable reductions in the number of components and layers used in each device enable physically smaller and less expensive devices that can substantially increase profit margins. Moreover, these advancements unlock new opportunities in medical procedures by enabling our devices to reach previously inaccessible anatomical areas.

Furthermore, these enhancements will fortify the physical and mechanical strength of our devices. This translates into products that are more robust, particularly beneficial for surgeons during challenging or prolonged medical procedures.

To validate these advancements, a fleet of Luminus devices will be manufactured to engage in medical procedure labs, where top surgeons will finalize our user friendly training protocols.
Our commitment to innovation extends beyond the laboratory: As in our past medical labs, we will prove these breakthroughs and disseminate our findings in key industry journals. Examples include achieving complete diagnostics within joints and sinuses, coupled with the ability to consistently target medication and regenerative injections.

As we progress with medical validations, we are diligently working with our manufacturer and regulatory firms to prepare and file for FDA clearance. All LuminusMicro departments and vendors have been instructed to adhere strictly to FDA submission protocols. Our regulatory management firms are primed to coordinate and execute this process, leveraging their expertise in securing rapid clearances for market-leading products in the surgical fields we are targeting. Reports indicate that each of their “predicate” devices, substantially equivalent to Luminus by FDA standards, received their respective 510K clearances in under 35 days. These reports serve as a definitive roadmap to achieving swift clearance for LuminusMicro devices.

LuminusMicro Appoints New COO, Earns NIH Recognition, and Prepares for ENT Market Launch

Q3 2023

Luminus Holdings is proud to announce the addition of several new members to our management team and advisory board, bringing extensive experience in commercialization, from product inception to global expansion. Among them is Paul Maccini, a seasoned senior executive with over three decades of leadership in Biotech and Med-Devices. Paul has successfully propelled multiple companies to surpass $1 billion USD in revenue in over 40 countries, by balancing market vision, operational efficiency, compliance, and world class service. Under Mr. Maccini, all Luminus departments will scale to meet demand, including production capacity, optimized supply chains, enhanced distribution channels, advanced product education and training.

LUMINUSMICRO RECOGNIZED BY US NIH AS FEATURE TECHNOLOGY

We are thrilled to announce that Precision Surgical Interventions (PSI), a division of the US National Institutes of Health (NIH) Cancer Research department, has selected LuminusMicro devices as a feature technology for presentation at their upcoming collaborative conference on September 7 in Chicago. This recognition underscores PSI’s commitment to accelerating the adoption of new diagnostic and therapeutic standards of care. Notably, this marks the second occasion that the NIH has acknowledged LuminusMicro as a breakthrough technology, citing previous collaboration with the Heart & Lung division on procedures that offer innovative access within this anatomy.

RECENT ACQUISITION IN THE ENT MARKET

In a significant development within the ENT market landscape, Medtronic has recently completed the acquisition of Intersect, an ENT pharmaceutical stent-implant company, for $1.1 billion. This acquisition holds profound relevance for Luminus as the optimal placement of their products in ENT anatomy necessitates direct endoscopic visualization. This capability is currently absent in doctors office settings using conventional devices. Until the launch of ENTnano, no device can offer this critical functionality without resorting to traumatic surgical procedures under extensive anesthesia.